Import/Export Regulatory Requirements for Medical Devices oR 0 i > Y = fe. = > o = AP ~'* DEPOSTopy DEC 23 1999 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration ''OMD PUBLICATIONS Publications of the Office of Medical Devices (OMD) are available as paper copies from either the U.S. Government Printing Office (GPO) or the National Technical Information Service (NTIS) as indicated by the GPO or PB prefix, respectively, on the ordering number. Individual publications are also available in microfiche from NTIS at $4.50 per copy. To receive all OMD reports in microfiche, at $1.00 each, you may establish a deposit account with NTIS and request automatic distribution of "FDA/HFZ" reports under the "Selected Research in Microfiche" program. Those publications without GPO or PB numbers are available only from OMD. Addresses for ordering are: Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402; National Technical Information Service, Springfield, VA 22161 (outside North America, prices are double those listed); and Office of Medical Devices, Food and Drug Administration, Rockville, MD 20857. All prices are subject to change. The FDA numbers have been assigned to some of these reports only recently and, therefore, may not reflect the year of publication. FDA 82-4031 FDA 82-4032 FDA 82-4052 FDA 82-4056 FDA 82-4059 FDA 82-4060 FDA 82-4061 FDA 82-4062 FDA 82-4063 FDA 82-4064 FDA 82-4068 FDA 82-4070 FDA 82-4072 FDA 82-4073 FDA 82-4074 FDA 82-4075 FDA 82-4103 FDA 82-4104 FDA 82-4107 FDA 82-4108 FDA 82-4114 FDA 82-4115 FDA 82-4117 Cosmetics - Related Injuries: Study of NEISS Data (PB 81-223497, $10.00). Detection of Abnormal Hemoglobins (PB 80-216138, $10.00). Instruction Manual - Aneurysm Clip Test System (PB 80-214034, $10.00). Laboratory Determination of Fibrinogen, Fibrin, and Degradation Products (PB 80-216120, $13.00).. Medical Device Reference File: $16.00). Medical Device Reference File: 152837, $16.00). Medical Device Reference File: Medical Device Reference File: 152803, $16.00). Medical Device Reference File: 81-152845, $16.00). Medical Device Reference File: Plastics: Syringes (PB 81-152811, $16.00). Particles in Medical Devices (PB 81-131625, $11.50). Proposed Performance Standard for In Vitro Diagnostic Devices Used in the Quantitative Measurement of Glucose in Serum or Plasma (PB 81-193237, $14.50). Quantitative Determination of Antiepileptic Drug Levels (PB 80-216088, $11.50). Quantitative Determination of Calcium (PB 80-216146, $13.00). Quantitative Determination of Serum Electrolytes (PB 80-216153, $10.00). Quantitative Determination of Theophylline (PB 80-216104, $10.00). Serological Diagnosis of Cryptococcal Infection (PB 80-216070, $8.50). Studies in the Determination of Reference Values for In Vitro Diagnostic Devices (PB 80-224892, $11.50). A Study of the Clinical Environmental Conditions Affecting Aneurysm Clips (PB 80-214026, $17.50). A Study of Safety and Performance Requirements for Cryosurgical Devices (PB 81- 124943, $17.50). Uterine Aspiration Devices (PB 81-215022, $19.00). a Replacements: A Study of Safety and Performance (PB 81-190985, 19.00). An Investigation of Rheumatoid Factor Detection Kits for Their Accuracy and Reproducibility (PB 81-114828, $11.50). Plastics: Airways and Tubes (PB 81-152829, Plastics: Blood and Solution Filters (PB 81- Plastics: Catheters (PB $1-152852, $16.00). Plastics: Contact and Intra-ocular Lenses (PB 81- Plastics: Intrauterine Contraceptive Devices (PB ''HHS Publication FDA 83-4160 Import/Export Regulatory Requirements for Medical Devices a 7 Prepared by Office of Small Manufacturers Assistance Office of Medical Devices January 1983 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration ; National Center for Devices and Radiological Health | \“\ ¢ ~ Rockville, Maryland 20857 ''oe PUBL BPAQACHO?R | '' K &S6 ts 19%3 PUB un FOREWORD In October 1982, FDA established the National Center for Devices and Radiological Health (NCDRH) by merging the Bureau of Medical Devices (now the Office of Medical Devices) and the Bureau of Radiological Health (now the Office of Radiological Health). Both Offices develop and implement national programs to protect the public health. The Office of Medical Devices is concerned with assuring the safety, effectiveness, and proper labeling of medical devices, while the Office of Radiological Health works to control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation and to ensure the safe, efficacious use of such radiation. The Center publishes the results of its work in scientific journals and in its own technical reports. These reports provide a mechanism for disseminating results of NCDRH and contractor projects. They are sold by the Government Printing Office and/or the National Technical Information Service. The Office of Radiological Health also makes its technical reports available to the World Health Organization under a memorandum of agreement between WHO and the Department of Health and Human Services. Three WHO collaborating Centers, established under the Bureau of Radiological Health, continue to function under NCDRH: WHO Collaborating Center for Standardization of Protection Against Nonionizing Radiations; WHO Collaborating Center for Training and General Tasks in Radiation Medicine; and WHO Collaborating Center for Nuclear Medicine. We welcome your comments and requests for further information. (WO John C. Villforth Director National Center for Devices and Radiological Health iii ''PREFACE The materials in this publication cover the basic regulatory requirements that manu- facturers must consider when they begin to export or import a medical device. It is important to know these requirements, to determine which ones are pertinent to your particular situation, and to follow the proper sequence or timetable for fulfilling them. The term "medical device" describes a large and diverse set of products. Regulation of these products is a challenging and complicated process, not only because of sheer volume and variety, but also because of their increasing importance in the delivery of patient health care. The Medical Device Amendments of May 28, 1976 mandated the establishment of. . "an identifiable office to provide technical and other non-financial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act." The Office of Small Manufacturers Assistance (OSMA) was established to meet these requirements. In addition to providing individual guidance and workshops, OSMA distributes a wide variety of printed materials, such as regulations, guidelines, policy statements, question-and-answer booklets, the SMA Memo, and other FDA documents that help manufacturers understand the substance and impact of requirements, as well as the simplest or most effective ways to meet them. The materials printed here are drawn from OSMA's ongoing programs of information and education. They should prove useful as a general reference on import-export requirements. The basic overview provided here will help you to get oriented and to focus on further specific questions you may wish to ask. It is OSMA's mission to assist you and to identify ways of complying with FDA requirements. If there is a need for more technical or detailed information, we will refer you to the appropriate authorities in the Department of Health and Human Services or to other government agencies that may be involved, such as the Department of Commerce. Feel free to visit, write, or call OSMA collect at (301) 427-7184. Wn H. Neal Dunning, Ph.D. Director Office of Small Manufacturers Assistance iv ''CONTENTS Page Foreword’... s) 0 2 ee we 8 ww ww ww ew te ew te we - iii Preface 2. 2 1 1 6 ew ew we ee we ew we we es tee 6 6 8 ee te 1V Abstract. 2. 1. 2 6 6 we we we ww ww ww ew ww wh we we ww ew vi Introductory Outline. . 2. 1 6 6 1 we we we we ew ee we we ew 1 Import/Export Provisions (FD&C Act, Section 801) ........... ; 7 Import/Export Protocol Requirements (21 CFR Part 807),...... ar 9 Table and Footnotes: Medical Device Import Requirements. ........ 19 Form FDA 701: Importer's Entry Notice. . ..... 2... 5 ee eee - 23 BMD's Foreign Liaison Listing . . . 1. 2. 2 6 6 2 we ew ew ee ew we 24 FDA Import Program Managers List . . . 2. 1. 1. 6 1 ee ee ew ew ew ~. 45 ''ABSTRACT Prepared by the Office of Small Manufacturers Assistance, Office of Medical Devices, NCDRH. Import/Export - Regulatory Requirements for Medical Devices. HHS Publication FDA 83-4160 (January 1983) (pp. 46). This publication covers basic regulatory requirements and outlines procedures that manufacturers must follow if they wish to import or export a medical device. On October 8, 1982, the Bureau of Radiological Health and the Bureau of Medical Devices were merged into a_ single organization, the National Center for Devices and Radiological Health. The two former bureaus are now designated as the Office of Radiological Health and the Office of Medical De- vices. Original publication of this reprint predates the merger, but titles, addresses, and phone numbers referred to in the text are current as of the reprint publication date. vi '' IMPORT/EXPORT OF MEDICAL DEVICES INTRODUCTORY OUTLINE FDA permission is not required in order to export a device that is legally mar- keted in me United States. It a a device Is is adulterated or misbranded within the without EDA permission provided that i it Is: e in accord with the specifications of the foreign purchaser e not in conflict with the laws of the country to which it is intended for export e labeled on the outside of the shipping package that it is intended for export, and e not sold or offered for sale in domestic commerce. Medical Device Export Procedures Devices that meet the foregoing four criteria but fail to comply with applicable requirements under Section 514 (performance standards), Section 515 (premar- ket approval), or Section 516 (banned devices) cannot be exported without prior authorization by FDA. ''To obtain such authorization, a person must submit a request to FDA, includ- ing the following information: e a description of the device intended for export e the status of the device in the United States (that is, whether it is investigational, banned, etc.) and e a statement from an appropriate official of the country to which the device is intended for export that the device has the approval of that country or, in countries that do not approve devices, that there is no objection to its importation. The statement from the foreign official must be in the English language, or accompanied by a certified translation. Requestors should flag their submissions "Export Request" and address them, along with any questions concerning exportation of medical devices, to the Division of Compliance Operations (HFK-110), Bureau of Medical Devices, 8757 Georgia Avenue, Silver Spring, Maryland 20910. On the basis of the information submitted, the Bureau of Medical Devices will determine whether exportation of the device would be contrary to the public health and safety and whether the device has the approval of the country to which it is intended for export (or, in countries that do not approve devices, whether the country has any objection to its importation). A device that meets the stated criteria, and for which BMD makes the requisite determinations, will be authorized for export. Authorization will be by letter from the Associate Director for Compliance, BMD. A copy of the letter will be sent to the responsible government office listed on BMD's Foreign Liaison List. If exportation is not approved, the Associate Director for Compliance, BMD, will issue a denial letter to the requestor. ''Import Procedures for Foreign-Made Devices Foreign manufacturers or foreign exporters wishing to distribute a foreign-made medical device in the U.S. must: e submit to FDA a completed device listing form (FDA 2892) for the device intended for export to the U.S. e maintain an historical listing file, containing package inserts, labeling, and advertisements for that device, and e permit FDA to inspect their establishments for compliance with good manufacturing practices (GMPs) and other regulatory requirements. A listing package (including forms and an instruction booklet) may be obtained from FDA headquarters, OSMA,or district offices. Device shipments offered for import by a manufacturer or exporter who has not listed cannot legally enter the country. The listing package also contains specific instructions for maintenance of the historical listing file. A foreign manufacturer or exporter may authorize his initial distributor — that is, a U.S. distributor who takes first possession of imported goods and causes their further distribution — to submit the listing form (FDA 2892) and maintain the historical listing file for him. In such cases, the initial distributor must be the exclusive (sole) distributor, and the foreign manufacturer or exporter must submit this information to FDA in the form of a written authorization. Initial distributors of devices imported into the U.S. must register their estab- lishments with FDA. e Failure to register as an initial distributor may result in detention of shipments at the port of entry. Initial distributors must also submit to FDA the name and address of the foreign manufacturer of each device intended for import. e If they initiate or develop specifications for the device, or repackage, or relabel it, such distributors must list the device with FDA. ''In addition, FDA requires initial distributors to submit a premarket notification if they are: e introducing a device into commercial distribution in the U.S. for the first. time e introducing for the first time a device or product line that another firm may already be marketing and _ that has not already been the subject of a premarket notification by another party, or e introducing or reintroducing a device undergoing a significant change or modification that could affect its safety or effectiveness. (Such changes or modifications might relate to design, manufacturing method, or in- tended use.) The initial distributor is exempt from premarket notification in cases where the device: e was distributed by others in the United States before May 28, 1976, or e has been previously reviewed under Section 510(k) and found to be equivalent. U.S. Procedures for Releasing Imported Device Shipments Customs requires that importers making formal entry of a shipment (one valued at more than $250) fulfill the following requirements: e submission of an entry package consisting of Con- sumption Entry Form (CF 7501), invoice, manifest, and other documents describing the article offered for import e payment of any import duty, and « a bond (money deposit) sufficient for the payment of liquidated damages in the event of default. ''Importer's entry notice (FDA 701): Importers of goods that come under the jurisdiction of the FD&C Act are required to inform the local FDA district office of each shipment. Either before or upon the shipment's arrival in the U.S.,they are requested to submit an Importer's Entry Notice (FDA-.701). These forms may be obtained from a broker or from the local. FDA district office or resident post. Registration and Listing Requirements: Sampling Procedures : When informed of a device shipment, FDA first determines whether the initial distributor has reg- istered, and the manufacturer listed, the device. If not, FDA issues a Notice of Detention and Hearing (EDA 718, formerly FD 70), detaining the shipment until the initial distributor has registered and/or the device is listed or listing has been initiated. Once registration and listing status have been de- termined, FDA will decide whether to sample the shipment or release it without sampling. This decision is based on FDA compliance programs then in effect; device history; FDA's current import alerts; historical information on the foreign manufacturer, exporter, or importer; and available investigational and analytical resources. If the shipment is to be sampled, FDA will issue a Notice of Sampling (FDA 712) to the importer. If analysis determines the sample to be in compliance with the FD&C Act, FDA will issue a Release Notice (FDA 717) and Customs will release the shipment to the importer. In eases where the device is determined to be in violation of the Act, FDA will detain the s shipment. Failure to bring the shipment into compliance will re- sult in re-export or destruction of the product. ''- An importer may petition to bring a violative shipment into compliance with the Act by submitting an FD 766: Application to Relabel or Perform Other Action (i.e., reconditioning). Any sorting, reprocessing, or relabel- ing permitted by FDA may be supervised by an FDA investigator at the importer's expense. e If the shipment is successfully reconditioned, FDA will issue an Originally Detained, Now Released (ODNR) form (FDA 717, modified) to the importer, who may then distribute the shipment. e If relabeling or reconditioning will not bring the ship- ment into compliance, FDA will issue a Notice of Refusal of Admission (FDA 772). Customs will then issue a Notice of Redelivery to the importer, who must either destroy or re-export the shipment within 90 days under Customs' supervision and at the importer's expense. Both foreign exporters and U.S. importers should realize that reconditioning of a violative imported product to bring it into compliance with the law is not a right, but a privilege. Abuse of the privilege, such as repeated shipments of the same illegal article, may result in denial of the privilege in the case of subsequent importations. ''Federal Food, Drug, and Cosmetic Act IMPORT/EXPORT PROVISIONS as Amended January 1980 CHAPTER VIII—IMPORTS AND EXPORTS SEc. 801 [381].*° (a) The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the rigk: to introduce testimony. The Secretary of Health and Human Sev.ves chall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 510 and shall request that if any drugs or devices manu- factured, prepared, propagated, compounded, or processed in an es- tablishment not so registered are imported or offered for import into the United States, samples of such drugs or devices be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that _ (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 520(f), or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treas- ury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act. (b) Pending decision as to the admission of an article being im- ported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as > Secs. 708 and 709 added by sec. 8 of P.L. 94-295. 35 Sec, 801 amended by sec. 701 of P.L. 91-513, and by secs. 3(f) and 4(b)(3) of P.L. 94-295. ''may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device, or cosmetic, final determination as to admis- sion of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, au- thorize the applicant to perform such relabeling or other action specified in such authorization (including destruction of export of rejected articles or portions thereof, as may be specified in the Secretary’s authorization). All such relabeling or other action pur- suant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury. (c) All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized, under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any future ieportanons made by such owner or consignee. (d) ** (1) A food, drug, device, or cosmetic intended for exnort shall not be deemed to be adulterated or misbranded under this Act if it— (A) accords to the specifications of the foreign pur- chaser, (B) is not in conflict with the laws of the country to which it is intended for export, (C) is labeled on the outside of the shipping package that it is intended for export, and (D) is not sold or offered for sale in domestic commerce. This paragraph does not authorize the exportation of any new an- imal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 512. (2) Paragraph (1) does not apply to any device— (A) which does not comply with an applicable require- ment of section 514 or 515, (B) which under section 520(g) is exempt from either such section, or, (C) which is a banned device under section 516, unless, in addition to the requirements of paragraph (1), the Sec- retary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export. ''21 CFR 807 PROTOCOL REQUIREMENTS for Importers/Exporters PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS OF DEVICES Subpart A—General Provisions Sec. 807.3 Definitions. Subpart B—Procedures for Domestic Device Establishments 807.20 Who must register and submit a device list. 807.21 Times for establishment registra- tion and device listing. 807.22 How and where to register establish- ments and list devices. 807.25 Information required or requested for establishment registration and device listing. . 807.26 Amendments to establishment regis- tration. . 807.30 . Updating device listing information. 807.31 Additional listing information. 807.35 Notification of registrant. 807.37 Inspection of establishment regis- tration and device listings. 807.39 Misbranding by reference to estab- lishment registration or to registration number. Subpart C—Registration Procedures for Foreign Device Establishments Sec. 807.40 Establishment registration and device listing for foreign manufacturers of devices. Subpart D—Exemptions 807.65 Exemptions for device establish- ments. Subpart E—Premarket Notification Procedures 807.81 When a premarket notification sub- mission is required. 807.85 Exemption from premarket notifica- tion. 807.87 Informatior. required in a premar- ket notification submission. 807.90 Format of a premarket notification submission. 807.95 Confidentiality of information. 807.97 Misbranding by reference to pre- market notification. AutuHority: Secs. 301(p), 501, 502, 510, 701(a), 52 Stat. 1049-1051 as amended, 1055, 76 Stat. 794 as amended, 86 Stat. 562 as amended, 90 Stat. 576-580 (21 U.S.C. 331(p), 351, 352, 360, 371(a)), unless otherwise noted. Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted. Subpart A—General Provisions § 807.3 Definitions. (a) “Act” means the Federal Food, Drug, and Cosmetic Act. (b) “Commercial distribution” means any distribution of a device intended for human use which is held or of- fered for sale but does not include the following: (1) Internal or interplant transfer of a device between’ establishments within the same parent, subsidiary, and/or affiliate company; (2) Any distribution of a device in- tended for human use which has in effect an approved exemption for in- vestigational use pursuant to section 520(g) of the act and Part 812 of this chapter; or (3) Any distribution of a device, before the effective date of Part 812 of this chapter, that was not introduced or delivered for introduction into in- terstate commerce for commercial dis- tribution before May 28, 1976, and that is classified into class III under ''Chapter I—Food and Drug Administration section 513(f) of the act: Provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premar- ket approval application as provided in section 515 of the act. (c) “Establishment” means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed. (d) “Manufacture, preparation, prop- agation, compounding, assembly, or processing” of a device means the making by chemical, physical, biologi- cal. or other procedures of any article that meets the definition of device in section 201(h) of the act. These terms include the following activities: (1) Repackaging or otherwise chang- ing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; (2) Initial distribution of imported devices; or (3) Initiation of specifications for de- vices that are manufactured by a second party for subsequent commer- cial distribution by the person initiat- ing specifications. (e) “Official correspondent” means the person designated by the owner or operator of an establishment as re- sponsible for the following: (1) The annual registration of the establishment; (2) Contact with the Food and Drug Administration for device listing; (3) Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner; and (4) The receipt of pertinent corre- spondence from the Food and Drug Administration directed to and involv- ing the owner or operator and/or any of the firm’s establishments. (f)“Owner or operator’ means the corporation, subsidiary, affiliated com- pany, partnership, or: proprietor di- rectly responsible for the activities of the registering establishment. (g) ‘Distributor’? means any person who furthers the marketing of a 10 § 807.3 device from the original place of man- ufacture to the person who mekes final delivery or sale to the ultimate consumer or user but who does not re- package or otherwise change the con- tainer, wrapper, or labeling of the device or device package. (h) Any term defined in section 201 of the act shall have that meaning. (i) “Restricted device’ means a device for which the Commissioner, by regulation under § 801.109 of this chapter or otherwise under section 520(e) of the act, has restricted sale, distribution, or use only upon the writ- ten or oral authorization of a practi- tioner licensed by law to administer or use the device or upon such other con- ditions as the Commissioner may pre- scribe. (j) “Classification name” means the term used by the Food and Drug Ad- ministration and its classification panels to describe a device or class of devices for purposes of classifying de- vices under section 513 of the act. (k) “Representative sampling of ad- vertisements” means typical advertis- ing material that gives the promotion- al claims made for the device. (1) “Representative sampling of any other labeling’ means typical labeling material (excluding labels and package inserts) that gives the promotional claims made for the device. (m) ‘Material change’’ includes any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may in- clude, but are not limited to, changes in the common or usual! or proprietary name, declared ingredients or compo- nents, intended use, contraindications, warnings, or instructions for use. Changes that are not material may in- clude graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling, changes in lot number, and, for devices where the biological activity or known composition differs with each lot produced, the labeling containing the actual values for each lot. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 ''§ 807.20 Stat. 564-580 (21 U.S.C. 431 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 197%) Subpart B—Procedures for Domestic Device Establishments § 807.20 Who must register and submit a device list. (a) An owner or operator of an es- tablishment not exempt under section 510(g) of the act or Subpart D of this part who is engaged in the manufac- ture, preparation, propagation, com- pounding, assembly, or processing of a devive intended for human use is re- quired to register and to submit listing information for those devices in com- mercial distribution, except that list- ing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or for- eign establishments under the control of one of these organizations when op- erations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term ‘‘device”’ includes all in vitro diagnostic prod- ucts and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Serv- ice Act. An owner or operator is re- quired to register its name, places of business, and all establishments and to list the devices whether or not the output of the establishments or any particular device so listed enters inter- state commerce. The registration and listing requirements shall pertain to any person who: (1) Initiates or develops specifica- tions for a device that is to be manu- factured by a second party for com- mercial distribution by the person ini- tiating specifications; (2) Manufactures for commercial dis- tribution a device either for itself or for another person. However, a person who only manufactures devices ac- cording to another person’s specifica- tions, for commercial distribution by the person initiating specifications, is not required to list those devices. (3) Repackages or relabels a device; (4) Initially distributes a device im- ported into the United States; or 1] Title 21—Food and Drugs (5) Manufactures components or ac- cessories which are ready to be used for any intended health-related pur- pose and are packaged or labeled for commercial distribution for such health-related purpose, e.g., blood fil- ters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks. (b) No registration or listing fee is required. Registration or listing does not constitute an admission or agree- ment or determination that a product is a device within the meaning of sec- tion 201(h) of the act. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978] § 807.21 Times for establishment registra- tion and device listing. An owner or operator of an estab- lishment entering into, or currently engaged in, an operation defined in § 807.3(c) and not currently registered shall register the establishment by Oc- tober 22, 1977, and submit device list- ing by October 10, 1978. An owner or operator of an establishment who has not previously entered into an oper- ation defined in § 807.3(c) shall rezis- ter within 30 days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its registration informa- tion annually between November 15 and December 31 and shall update its device listing information every June and December or, at its discretion, at the time the change occurs. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (43 FR 37997, Aug. 25, 1978] ''Chapter I—Food and Drug Administration § 807.22 How and where to register estab- lishments and list devices. (a) The first registration of a device establishment shall be on form FD- 2891 (Initial Registration of Device Es- tablishments). Forms are obtainable on request from the Bureau of Medi- cal Devices (HFK-124), Food and Drug Administration, Department of Health, Education, and Welfare, 8757 Georgia Avenue, Silver Spring, Md. 20910, or from the Food and Drug Ad- ministration district offices. Subse- quent annual registration shall be ac- complished on form FD-2891a (Regis- tration of Device Establishment), which will be furnished by the Food and Drug Administration before No- vember 15 of each year to establish- ments whose registration for that year was validated under § 807.35(a). The completed form shall be mailed to the above-designated address before De- cember 31 of that year. (b) The initial listing of devices and subsequent June and December updat- ings shall be on form FD-2892 (Medi- cal Device Listing). Forms are obtain- able upon request as described in para- graph (a) of this section. A separate form FD-2892 shall be submitted for each device or device class listed with the Food and Drug Administration. Devices having variations in physical characteristics such as size, package, shape, color, or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device. In lieu of form FD-2892, tapes for computer input or hard copy comput- er output may by submitted if equiva- lent in all elements of information as specified in form FD-2892. All formats proposed for use in lieu of form FD- 2892 require initial review and approv- al by the Food and Drug Administra- tion. (c) The listing obligations of the ini- tial distributor within the United States of an imported device are satis- fied as follows: (1) For those imported devices for which the initial distributor has also initiated or developed the specifica- tions, form FD-2892 shall be submit- ted and the historical file maintained by the initial distributor. 12 § 807.25 (2) For those imported devices for which the initial distributor repack- ages or relabels the device, form FD- 2892 shall be submitted and the his- torical file maintained by the initial distributor. (3) The initial distributor is not re- quired to submit a form FD-2892 for those imported devices for which such distributor did not initiate or develop the specifications for the device or re- package or relabel the device. Howev- er, the initial distributor shall submit, for each device, the name and address of the foreign manufacturer. Initial distributors shall also be prepared to submit, when requested by the Food and Drug Administration, the propri- etary name, if any, and the common or usual name of each device for which they are the initial distributors. (4) The initial distributor shall update the information required by paragraphs (c) (1), (2), and (3) of this section at the intervals specified in § 807.30 (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 194 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (43 FR 37997, Aug. 25, 1978] § 807.25 Information required or request- ed for establishment registration and device listing. (a) Form FD-2891 and Form FD- 2891(a) are the approved forms for ini- tially providing the information re- quired by the act and for providing annual registration, respectively. The required information includes. the name and street address of the device establishment, including post office ZIP Code, all trade names used by the establishment, and the business trad- ing name of the owner or operator of such establishment. (b) The owner or operator shall identify the device activities of the es- tablishment such as manufacturing,. repackaging, or distributing of import- ed devices and identify any other FDA registries in which the establishment is registered. (c) Each owner or operator is re- quired to maintain a listing of all offi- cers, directors, and partners for each ''$ 807.26 establishment he registers and to fur- nish this information to the Food and Drug Administration upon request. (d) Each owner or operator shall provide the name of an official corre- spondent who will serve as a point of contact between the Food and Drug Administration and the establishment for matters relating to the registration of device establishments and the list- ing of device products. All future cor- respondence relating to registration, including requests for the names of partners, officers, and directors, will be directed to this official correspon- dent. In the event no person is desig- nated by the owner or operator, the owner or operator of the establish- ment will be the official correspon- dent. (e) The designation of an official correspondent does not in any manner affect the liability of the owner or op- erator of the establishment ‘or any other individual under section 301(p) or any other provision of the act. (f) Form FD-2892 is the approved form for providing the device listing information required by the act. This required information includes the fol- lowing: (1) The identification by classifica- tion name and number, proprietary name, and common or usual name of each device being manufactured, pre- pared, propagated, compounded, or processed for commercial distribution that has not been included in any list of devices previously submitted on form FD-2892. (2) The Code of Federal Regulations citation for any applicable standard for the device under section 514 of the act or section 358 of the Public Health Service Act. ; (3) The assigned Food and Drug Ad- ministration number of the approved application for each device listed that is subject to section 505, 507, or 515 of the act. (4) The name, registration number, and establishment type of every do- mestic or foreign device establishment under joint ownership and control of the owner or operator at which the device is manufactured, repackaged, or relabeled. Title 21—Food and Drugs (5) Whether the device, as labeled, is intended for distribution to and use by the general public. (6) Other general information re- quested on form FD-2892, i.e., (i) if the submission refers to a previously listed device, as in the case of an update, the document number from the initial listing document for the device, (ii) the reason for submission, (iii) the date on which the reason for submission occurred, (iv) the date that the form FD-2892 was completed, (v) the owner’s or operator’s name and identification number. (7) Labeling or other descriptive in- formation (e.g., sgecification sheets or catalogs) adequate to describe the in- tended use of a device when the owner or operator is unable to find on the Food and Drug Administration list in the device listing package, an appro- priate classification name for the device. (Secs. 301 (p) and (q)(2), 501, 502, 508; 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978) § 807.26 Amendments to establishment registration. Changes in individual ownership, corporate or partnership structure, or location of an operation defined in § 807.3(c) shall be submitted on Form FD-2891(a). This information shall be submitted within 30 days of such changes. Changes in the names of offi- cers and/or’ directors of the corporation(s) shall be filed with the establishment’s official correspondent and shall be provided to the Food and Drug Administration upon receipt of a written request for this information. § 807.30 Updating device listing informa- tion. (a) Form FD-2892 shall be used to update device listing information. The preprinted original document number of each form FD-2892 on which the device was initially listed shall appear in block 2 on the form subsequently used to update the listing information 13 ''Chapter I—Food and Drug Administration for the device and on any correspond- ence related to the device. (b) An owner or operator shall update the device listing information during each June and December or, at its discretion, at the time the change occurs. Conditions that require updat- ing and information to be submitted for each of these updates are as fol- lows: (1) If an owner or operator intro- duces into commercial distribution a device identified with a classification name not currently listed by the owner or operator, then the owner or operator must submit form FD-2892 containing all the information re- quired by § 807.25(f). (2) If an owner or operator discon- tinues commercial distribution of all devices in the same device class, i.e., with the same classification name, the owner or operator must submit form FD-2892 containing the original docu- ment number of the form FD-2892 on which the device class was initially listed, the reason for submission, the date of discontinuance, the owner or operator’s name and _ identification number, the classification name and number, the proprietary name, and the common or usual name of the dis- continued device. (3) If commercial distribution of a discontinued device identified on a form FD-2892 filed under paragraph (b)(2) of this section is resumed, the owner or operator must submit on form FD-2892 a notice of resumption containing: the original document number of the form initially used to list that device class, the reason for submission, date of resumption, and all other information required by § 807.25(f). (4) If one or more classification names for a previously listed device with multiple classification names has been added or deleted, the owner or operator must supply the original doc- ument number from the form FD-2892 - on which the device was initially listed and a supplemental sheet identifying the names of any new or deleted clas- sification names. (5) Other changes to information on form FD-2892 will be updated as fol- lows: 14 § 807.31 (i) Whenever a change occurs only in the owner or operator name (block 6) or number (block 7), e.g., whenever one company’s device line is purchased by another owner or operator, it will not be necessary to supply a separate form FD-2892 for each device. In such cases, the new owner or operator must follow the procedures in § 807.26 and submit a letter informing the Food and Drug Administration of the origi- nal document number from form FD- 2892 on which each device was initially listed for those devices affected by the change in ownership. (ii) The owner or operator must also submit update information whenever changes occur to the responses to the questions in blocks 12, 12a, 13, 13a, and 14 on form FD-2892, or whenever establishment registration numbers, establishment names, and/or activities are added to or deleted from blocks 15, 16, and 17 of form FD-2892. The owner or operator must supply the original document number from the form FD-2892 on which the device was initially listed, the reason for submis- sion, and all other information re- quired by § 807.25(f). (6) Updating is not required if the above information has not changed since the previously submitted list. Also, updating is not required if changes occur in proprietary names, in common or usual names (blocks 10 and 11 of form FD-2892), or to supplemen- tal lists of unclassified components or accessories. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amenaed, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (43 FR 37998, Aug. 25, 1978] § 807.31 Additional listing information. (a) Each owner or operator shall maintain a historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing, as follows: (1) For each device subject to section 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device; ''§ 807.35 (2) For each restricted device, a copy of all labeling and advertisements for the device; (3) For each device that is neither restricted nor subject to section 514 or 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other labeling. (b) In addition to the requirements set forth in paragraph (a) of this sec- tion, each owner or operator shall maintain in the historical file any la- beling or advertisements in which a material change has been made any- time after initial listing. (c) Each owner or operator may dis- card labeling and advertisements from the nistorical file as follows: (1) Five years after the date of the last shipment of a discontinued device by an owner or operator, (i) All labeling that was not in use at the time of the last shipment of the device may be discarded, and, (ii) All advertisements may be dis- carded, except for a representative sampling of all advertisements in use during the 12 months immediately preceding the last shipment of a re- stricted device. (2) All labeling that was in use at the time of the last shipment of a discon- tinued device and a _ representative sampling of all advertisements in use during the 12 months immediately preceding the last shipment of a re- stricted device may be discarded 5 years after the date of the last ship- ment of the device or at the end of the anticipated useful life of the device. (d) Location of the file: (1) Currently existing systems for maintenance of labeling and advertis- ing may be used for the purpose of maintaining the historical file as long as the information included in the sys- tems fulfills the requirements of this section, but only if the labeling and advertisements are retrievable in a timely manner. (2) The contents of the historical file may be physically located in more than one place in the establishment or in more than one establishment pro- vided there exists joint ownership and control among all the establishments maintaining the historical file. If no joint ownership and control exists, the registered establishment must provide Title 21—Food and Drugs the Food and Drug Administration with a letter authorizing the establish- ment outside its control to maintain the historical file. (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only upon spe- cific request, the following informa- tion: (1) For a device subject to section 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device. : (2) For a device that is a restricted device, a copy of all labeling for the device, a representative sampling of advertisements for the device, and for good cause, a copy of all advertise- ments for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an explanation of the basis for such re- quest. (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the label and package insert for the device and a representative sampling of any other labeling for the device. (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that the device is not subject to section 514 or 515 of the act. (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined the device is not a restricted device. (6) For a particular device, a state- ment of the basis for determining that the product is a device rather than a drug. (7) For a device that the owner or operator has manufactured for distri- bution under a label other than its own, the names of all distributors for whom it has been manufactured (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) [43 FR 37999, Aug. 25, 1978] § 807.35 Notification of registrant. (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a validated 15 ''Chapter I—Food and Drug Administration copy of Form FD-2891 or Form FD- 2891(a) (whichever is applicable) as evidence of registration. A permanent registration number will be assigned to each device establishment registered in accordance with these regulations. (b) Owners and operators of device establishments who also manufacture or process blood or drug products at the same establishment shall also reg- ister with the Bureau of Biologics and Bureau of Drugs, as appropriate. Blood products shall be listed with the Bureau of Biologics, Food and Drug Administration, pursuant to Part 607 of this chapter; drug products shall be listed with the Bureau of Drugs, Food and Drug Administration, pursuant to Part 207 of this chapter. (c) Although establishment registra- tion and device listing are required to engage in the device activities de- scribed in § 807.20, validation of regis- tration and the assignment of a device listing number in itself does not estab- lish that the holder of the registration is legally qualified to deal in such de- vices and does not represent a determi- nation by the Food and Drug Adminis- tration as to the status of any device. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) (42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37999, Aug. 25, 1978] § 807.37 Inspection of establishment regis- tration and device listings. (a) A copy of the forms FD-2891 and FD-2891a filed by the registrant will be available for inspection in accord- ance with section 510(f) of the act, at the Bureau of Medical Devices (HFK- 124), Food and Drug Administration, Department of Health, Education, and Welfare, 8757 Georgia Avenue, Silver Spring, Md. 20910. In addition, there will be available for inspection at each of the Food and Drug Administration district offices the same information for firms within the geographical area of such district office. Upon request, verification of registration number or location of a registered establishment will be provided. § 807.40 (b)1) The following information filed under the device listing requvire- ments will be available for public dis- closure: (i) Each form FD-2892 submitted; (ii) All labels submitted; diii) All labeling submitted; (iv) All advertisements submitted; (v) All data or information that has already become a matter of public knowledge. (2) Requests for device listing infor- mation identified in paragraph (b)(1) of this section should be directed to the Bureau of Medical Devices (HFK- 124), Food and Drug Administration, Department of Health, Education, and Welfare, 8757 Georgia Avenue, Silver Spring, Md. 20910. (3) Requests for device listing infor- mation not identified in paragraph (b)(1) of this section shall be submit- ted and handled in accordance with Part 20 of this chapter. (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371¢a))) (43 FR 37999, Aug. 25, 1978] § 807.39 Misbranding by reference to es- tablishment registration or to registra- tion number. Registration of a device establish- ment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that cre- ates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding. Subpart C—Registration Procedures for Foreign Device Establishments § 807.40 Establishment registration and device listing for foreign manufactur- ers of devices. (a) Foreign device establishments that export devices into the United States are requested to register in ac- cordance with the procedures of Sub- part B of this part, unless exempt under Subpart D of this part. (b) Foreign device establishments that export devices into the United 16 ''§ 807.65 States, whether or not the establish- ment is registered, shall comply with the device listing requirements unless exempt from registration as stated in § 807.65. Those foreign owners or oper- ators for which there exists joint own- ership and control with a domestic es- tablishment may have the domestic es- tablishment submit listing informa- tion and maintain the historical file. A foreign owner or operator may author- ize a domestic initial distributor to submit listing information when joint ownexship and control does not exist, only if: (1) The domestic distributor is the sole initial distributor for the foreign owner or operator’s device; and (2) The foreign owner or operator submits a letter to the Food and Drug Administration authorizing the initial distributor to list on its behalf and maintain the historical file. (c) Except for a device imported or offered for import that has in effect an approved exemption for investiga- tional use under section 520(g) of the act, a device may not be imported from a foreign device establishment into the United States unless it is listed at the interval specified for up- dating device listing information in § 807.30(b). The device listing informa- tion shall be in the English language. (d) Foreign device establishments shall submit, as part of the device list- ing, the name and address of the es- tablishment and the name of the indi- vidual responsible for submitting device listing information. Any changes in this information shall be reported to the Food and Drug Admin- istration at the intervals specified for updating device listing information in § 807.30(b). (Secs. 301 (p) and (q)(2), 501, 502, 508, 510, 519, 701(a), 52 Stat. 1042-1043 as amended, 1049-1050 as amended, 1055, 76 Stat. 789, 794 as amended, 86 Stat. 562 as amended, 90 Stat. 564-580 (21 U.S.C. 331 (p) and (q)(2), 351, 352, 358, 360, 360i, 371(a))) [43 FR 37999, Aug. 25, 1978) Subpart D—Exemptions § 807.65 Exemptions for device establish- ments. The following classes of persons are exempt from registration in accord- Title 21—Food and Drugs ance with § 807.20 under the provisions of section 510(g) (1), (2), and (3) of the act, or because the Commissioner has found, under section 510(g)(4) of the act, that such registration is not neces- sary for the protection of the public health: (a) A manufacturer of raw materials or components to be used in the manu- facture or assembly of a device who would otherwise not be required to register under the provisions of this part. (b) A manufacturer of devices to be used solely for veterinary purposes. (c) A manufacturer of general pur- pose articles such as chemical reagents or laboratory eqiipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses. (d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical supply out- lets, or other similar retail establish- ments dispensing or selling devices in the regular course of business at the retail level. This exemption also ap- plies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly la- beled health aid such as an elastic bandage or crutch, indicating ‘‘distrib- uted by” or “manufactured for’ fol- lowed by the name of the pharmacy. (f) Persons who manufacture, pre- pare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not intro- duce such devices into commercial dis- tribution. (g) Persons who handle devices but make no revisions to such devices or their immediate containers, such as wholesalers or warehousers. (h) Carriers by reason of their re- ceipt, carriage, holding or delivery of devices in the usual course of business as carriers. (i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be de- rived from the use of a device; for ex- 17 ''Chapter i—Food and Drug Administration ample, a hearing aid dispenser, opti- cian, clinicai laboratory, assembler of diagnostic X-ray systems, and person- nel from a hospital, clinic, dental labo- ratory, orthotic or prosthetic retail fa- cility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device. Subpart E—Premarket Notification Procedures § 807.81 When a premarket notification submission is required. (a) Except as provided in paragraph (b) uf this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria: (1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantial- ly equivalent to, (i) a device in com- mercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been re- classified into class I or II. (2) The device is being introduced into commercial distribution for the first time by a person required to reg- ister, whether or not the device meets the criteria in paragraph (a)(1) of this section. (3) The device is one that the person currently has in commercial! distribu- tion or is reintroducing into commer- cial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The fol- lowing constitute significant changes or modifications that require a pre- market notification: (i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, 18 § 807.85 chemical composition, energy sour. or manufacturing process. (ii) A major change or modification in the intended use of the device. (b) A premarket notification under this subpart is not required for a device for which a premarket approval application under section 515 of the act, or for which a petition to reclas- sify under section 513(f)(2) of the act, is pending before the Food and Drug Administration, : (c) In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in § 1000.3 of this chapter, shall comply with the reporting requirements of Part 1002 of this chapter. § 807.85 Exemption from premarket noti- fication. (a) A device is exempt from the pre- market notification requirements of this subpart if the device intended for introduction into commercial distribu- tion is not generally available in fin- ished form for purchase and is not of- fered through labeling or advertising by the manufacturer, importer, or dis- tributor thereof for commercial distri- bution, and the device meets one of the following conditions: (1) It is intended for use by a patient. named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons). (b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the pre- market notification requirements of this subpart if: (1) The device was in commercial dis- tribution before May 28, 1976; or (2) A premarket notification submis- sion was filed by another person. ''MEDICAL DEVICE IMPORT REQUIREMENTS Table and Footnotes 19 ''02 Table | Medical Device Import Requirements RECEIVER RESPONSIBLE OF FORM PARTY REQUIRED FORM OR FORMAT é OR FORMAT IMPORT STAGE IMPORT REQUIREMENT 1 BEFORE IMPORT 1.1 Register Establishment 1.2 List Device 1.3 Good Manufacturing Practices Regulation 1.4 Performance Standard 1.5 Premarket Notification 1.6 Premarket Approval Application 1.7 Marking Country of Origin 1.8 Labeling 2 DURING IMPORT 2.1 Notification of Importer’s Number 2.2 Entry Record 2.3 Consumption Entry 2.4 Immediate Delivery/Consumption Entry Bond 2.5 Special Customs Invoice 2.6 Immediate Delivery Application 2.7 Importer’s Entry Notice 2.8 Radiation Control Standards Declaration 2.9 Importer’s Entry Notice 2.10 May Proceed Notice 3 AFTER IMPORT 3.1 Notice of Detention and Hearing 3.2 Notice of Sampling 3.3 Release Notice 3.4 Notice of Detention and Hearing 3.5 Application to Relabel/Recondition 3.6 Originally Detained Now Released 3.7 Notice of Refusal of Admission 3.8 Notice of Redelivery 3.9 Destroy or Re-export '' 1d lforeign manufacturers who import devices to the U.S. are requested to register their establishment with FDA under 21 CFR 807.40(a). 2Either the foreign manufacturer or the distributor who imports devices into the U.S. are required to list their products with FDA under 21 U.S.C. 360( 3). However, 21 CFR 807.40(a) permits the initial/sole distributor to list on behalf of the foreign manufacturer, provided that the manufacturer has authorized the importer, in a letter to FDA, to do so on his behalf and to maintain the required Historical Listing File. In addition, an initial distributor that initiates or develops specifications for the device, or repackages or relabels the device must list with FDA under 21 CFR 807.22(c)(1). 3Foreign manufacturers and initial distributors of imported devices that initiate specifications for devices must comply with the good manufacturing practices (GMP) regulation (21 CFR 820). 41£ and when a performance standard is developed for a medical device that FDA's classification panel has placed in Class II, the foreign manufacturer must also meet that standard. San importer must submit a premarket notification (510(k)) to FDA at least 90 days before marketing a device if they are introducing a device into commercial distribution for the first time; introducing a new device or product line for the first time yourself which may already be marketed by another firm; or introducing or reintroducing a device for which there is to be a significant change or modification which could affect the safety or effectiveness of the device. 61f, after reviewing a premarket notification, FDA determines the device to be new, it is automatically classified into Class III. Class IIL devices cannot be introduced in this country without an approved premarket approval application (PMA), a completed product development protocol (PDP), or an investigational device exemption (IDE). Details on how to submit a PMA, PDP, or an IDE may be found in this workbook. 7 ; Manufacturers and producers of general medical devices should label their products in accordance with the labeling provisions contained in 21 CFR 801 entitled "Part 801 - Labeling," while manufacturers and producers of in vitro diagnostic products for human use should label their products in accordance with the labeling provisions contained in 21 CFR 809 entitled "Part 809 - In Vitro Diagnostic Products for Human Use." The U.S. Customs Service requires this form if importers are bringing products into the U.S. for the first time. The U.S. Customs Service requires this form from the importer at the time of entry. 10 ‘ ; : : J : : ' . The U.S. Customs Service requires importers making a formal entry of a shipment (one valued in excess of $250) to submit an entry package. This consists of a CF 7501, a commercial invoice, a manifest, a bill of lading, other documents describing the articles offered for import, plus payment of any import duty. 1 oeas An importer may submit this form if the U.S. Customs Service determines that you have previously submitted all entry forms correctly. The privilege of submitting a CF 3461 is that it grants you the right to deliver your merchandise immediately and then allows you 10 working days in which to submit your entry forms and pay your import duty. 2 ; 7 ; i ‘The importer must submit this form to the U.S. Customs Service. This form is required from an importer if the device being imported is subject to radiological health controls. 14 the U.S. Customs Service must submit an "Importer's Entry Notice" (FDA 701) to FDA with a copy of the following: commerical invoice, CF 7501, bill of lading, CF 3461 (if applicable), FD 2877 (if applicable), and a certificate on any delivery item in the entry. ''6S If FDA determines that the shipment is acceptable and decides not to sample, FDA issues this form. 16 If FDA determines that an initial distributor has not registered his establishment and/or a manufacturer has not listed his device(s), FDA will issue this form and detain the shipment until the initial distributor has registered and/or the device is listed or listing has been initiated. If FDA determines that sampling is necessary in order to assure the safety and efficacy of the device, FDA will issue this form to the importer. A modified FDA 712 permits movement of the entry to a single location within the local FDA sampling area. 18 £9 If the analysis determines the sample to be in compliance, FDA will issue this form and the U.S. Customs Service will release the shipment to the importer. “If the analysis determines the sample to be in violation, FDA will issue this form and detain the shipment. Failure to bring the shipment into compliance will result in re-export or destruction. 20 Z2 23 Prior to bringing a violative shipment into compliance, an importer must submit this form to FDA. L If the violative shipment is successfully reconditioned, FDA will issue this form with the words ORIGINALLY DETAINED NOW RELEASED, in bold type, to the importer. If relabeling or reconditioning doesn't bring the shipment into compliance, FDA will issue this form to the importer. The U.S. Customs Service will issue this form to the importer after FDA issues a FD 772. The importer must then destroy the merchandise or export it from the U.S., in both cases, however, the importer must act under the supervision of Customs. ''ENTRY DATA TAKEN FROM ID Advance | | Number Notice ie Manifest Date IT Advance mmerciat Notice involee attached Fc] DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE FOOD AND DRUG ADMINISTRATION FORM APPROVED OMB No. 57R0104 ENTRY NO. AND DATE BILL OF LADING NO. PORT OF LADING COUNTRY OF ORIGIN PORT OF UNLOADING PORT OF ENTRY BROKER'S REF NO. Cc. H. BOX NO. VALUE OF ENTRY IN U.S. $ CONTAINER NO. IMPORTING VESSEL ARRIVAL DATE FOR THE ACCOUNT OF Consignee ‘Name & Address) IMPORTER OF RECORD (Name & Address) MANUFACTURER/SHIPPER (Name & Address BROKER (If not same as above) LOCATION OF LOT OATE AVAIL Nuouer Related of Items Sample sampled from this Numbers ntry. MONITOR: THIS IMPORTATION MAY PROCEED Without FDA Examination This notice does not preclude action should the merchandise later be found violative. VALID ONLY IF SIGNED SIGNED FOA Representative OATE (FOR BROKER'S USE) IMPORTANT NOTICE — An import shipment must be held intact locally pending further notice from FDA. With the advance notice, or otherwise, Broker or Importer must inform FDA of the following: 1. Earliest date the shipment will be available for sampling. 2. Location in local area of the shipment on that date. 3. Breakdown as shown on the invoice-number and size of units each lot, and $ value each lot. FORM FD 701 (6/77) HEADER SHEET (F0700 SET) 23 IMPORTER’'S ENTRY NOTICE GENERAL DESCRIPTION OF SHIPMENT arty. PACKAGED ITEMS BROKER: 1. Type fill-in on the form except for the shaded area. Remove bottom copy (white) with paper, and retain for your use. Send the rest of the set intact with the import documents (1.0., comm. invoice, con. entry, etc. its carbon to your local FDA Import Office. ''BMD’s FOREIGN LIAISON LISTING as of April 1982 [See *NOTE below] AFGHANISTAN 1 Afghanistan Embassy 2341 Wyaming Avenue, N.W. Washington, D.C. 20008 U.S.A. ALGERIA Attache 1 Embassy of Algeria 2118 Kalorama Rd., N.W. Washington, D.C. 20008 U.S.A. *NOTE: part of the address. ARGENTINA Secretaria de Estado de Salud Publica Relaciones Sanitarias Internacionales Defensa 120 - 4 - Of. 4027 1345 Buenos Aires, Argentina South America AUSTRALIA Assistant Director General Therapeutic Goods Branch P.O. Box 100 Woden A.C.T. 2606 Australia AUSTRIA University Dozent Bundesministerium fuer Gesundheit und Umweltschutz, Sektion II Stubenring 1 A-1010 Wien, Austria Europe Ratsed numbers that appear in some of the entries are not They refer to footnotes, which are grouped together at the end of this listing. 24 ''BAHAMAS Chief Medical Officer Ministry of Health and National Insurance P.O. Box N 3729 Nassau, N.P., Bahamas Cammonwealth of the Bahama Islands BAHRAIN 1 Bahrain Embassy 2600 Virginia Avenue, N.W. Washington, D.C. 20037 U.S.A. BANGLADESH Director Drug Administration Ministry of Health and Population Control (Health Division) 80 Motijheel Commercial Area Dacca, Bangladesh Asia BARBADOS First Secre Embassy of Barbados 2144 Wyoming Avenue, N.W. Washington, D.C. 20008 U.S.A. BELGIUM 2 Economic Minister Embassy of Belgium 3330 Garfield St., N.W. Washington, D.C. 20008 U.S.A. BELGIUM 3 The Pharmaceutical Inspectorate Ministry of Public Health Vesalius gebouw 3° Verdieping Administratief Centrum 1010 Brussel, Belgium Europe BENIN Directeur General de 1'ONP Office National de Pharmacie BP 1255 Cotonou Republique Populaire du Benin Africa BOLIVIA Ministerio de Prevision Social y Salud Publica Plaza Franz Tamayo La Paz, Bolivia South America BOTSWANA Permanent Secretary Ministry of Health Private Bag 0038 Gaborone, Botswana Africa BRAZIL Ministerio de Saude Secretario de Vigilancia Sanitaria Divisao Nacional de Vigilancia Sanitaria de Medicamentos — DIMED Avenida Brazil, 4036, e” andar, sala 602 20930 - Rio de Janeiro, RJ Brazil South America 25 ''BULGARIA Information Officer Bulgarian Embassy 2100 16th Street, N.W. Washington, D.C. 20009 U.S.A. he BURMA Chancellor” Embassy of Burma 2300 S Street, N.W. Washington, D.C. 20008 U.S.A. BURUNDI The Ambassador! Burundi Embassy 2717 Connecticut Avenue, N.W. Washington, D.C. 20008 U.S.A. 26 CAMEROON The Ministry of Public Health P.O. Yaounde United Republic of Cameroon Africa CANADA Director Bureau of Medical Devices Health and Welfare of Canada Health Protection Branch Environmental Health Directorate Brooke Claxton Building Tunney's Pasture Ottawa, Ontario Canada KIA OL2 CAPE VERDE Ministry of Health and Social Affairs Secretaria-Geral do Ministerio da Saude e Assuntos Sociais Praia, Cape Verde Cape Verde Islands CENTRAL AFRICAN EMPIRE Directeur General de la Sante Publique au Ministere de la Sante et de la Population Empire Centrafricain Africa CHAD Ministre de la Sante Publique et des Affaires Sociales N'DJAMENA (REPUBLIQUE DU TCHAD) Africa ''CHILE Ministerio de Salud Jefe de Coordinacion y Planes Mac Iver 541 Piso 3 Santiago, Chile South America CHINA ' Embassy of the People s Republic of China 1 2300 Connecticut Avenue, N.W. Washington, D.C. 20008 U.S.A. COLOMBIA Ministro de Salud Calle 16 N 7-39 Bogota, Colambia South America COSTA RICA Ministro de Salud Publica San Jose, Costa Rica Central America CYPRUS Director Pharmaceutical Services Ministry of Health Republic of Cyprus Nicosia, Cyprus Cyprus Island CZECHOSLOVAKIA Office for Standards and Measures Department for International Cooperation Urad pro normalizaci a mereni Oddeleni mezinarodne spoluprace Vaclavske nam. 19 110 00 Praha 1, Czechoslovakia Europe 27 DENMARK Sundhedsstyrelsen St. Kongensgade 1 1264 Copenhagen K, Denmark Europe DOMINICAN REPUBLIC Secretaria de Estado de Salud Publica y Asistencia Social Ensanche La Fe Santo Domingo, Republica Dominicana Hispaniola Island West Indies 4 '' ECUADOR Direccion Nacional Control Sanitario Juan Larrea No. 444—Quito Ecuador South America EGYPT Director General of Importation Department 6 El-Shwarby St. Cairo, Egypt Africa - EL SALVADOR Presidente del Consejo Superior de Salud Publica Avenida Espana No 736 San Salvador, El Salvador, C.A. Central America ETHIOPIA 1 Third Secretary Embassy of Ethiopia 2134 Kalorama Road, N.W. Washington, D.C. 20008 U.S.A. 28 FIJI Permanent Representative Fiji Mission to the United Nations One United Nations Plaza (26th Floor) New York, NY 10017 U.S.A. FINLAND Sosiaali ja terveysministerio Snellmanninkatu 4-6 SF-00170 Helsinki 17, Finland Europe FRANCE ' Ministere de la Saute et de la Securite Sociale 1, place de Fontenoy 75700 Paris, Republique Francaise Europe ''GABONESE REPUBLIC Embassy of the’ Republic of Gabon! 2034 20th Street, N.W. Washington, D.C. 20009 U.S.A. GERMANY, WEST Ministerialrat Referat Va 5 Bundesministerium fur Arbeit und Sozialordnung : Postfach 14 02 80 5300 Bonn-Duisdorf Federal Republic of West Germany Europe GHANA Director of Medical Services c/o P.O. Box M.44 Accra, Ghana Africa GREAT BRITAIN (See United Kingdam of Great Britain) GREECE First Secretary Ministry of Social Services International Relations Division 17 Aristotelous Str Athens, Greece Europe GRENADA Permanent Secretary Ministry of Health St. George's Grenada Windward Island West Indies GUATEMALA Embassy of Guatemala 2220 R Street, N.W. Washington, D.C. 20008 U.S.A. GUINEA 1 Embassy of Guinea 2112 Leroy Place, N.W. Washington, D.C. 20008 U.S.A. GUINEA — BISSAU Minister of Health and Social Welfare Bissau Guinea, Bissau Africa GUYANA Government Analyst Commissioner of Food and tee 19/21 Lyng and Evans Streets Georgetown, Guyana South America ''os a HAITI 4 Ministere Sante Publique Port-Au-—Prince Haiti West Indies HONDURAS Director, General de Salud Tegucigalpa, D.C., Honduras Central America HUNGARY 1 Eng., MSEE, B. Sc. Econ. Commercial Secretary Hungarian Embassy 150 E. 58th Street, NY 10022 U.S.A. 30 ICELAND 1 Embassy of Iceland 2022 Connecticut Avenue, N.W. Washington, D.C. 20008 U.S.A. INDIA e Embassy of India 2107 Massachusetts Avenue, N.W. Washington, D.C. 20008 U.S.A. INDONESIA Information Officer Indonesian Embassy 2020 Massachusetts Avenue, N.W. Washington, D.C. 20036 UsS