1234567-7/1/97-002-C etc. For removals, the number will appear as follows: 1234567-6/1/97-001-R and 1234567-7/1/97002-R, etc. Firms that do not have a seven digit registration number may use seven zeros followed by the month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for corrections and 0000000-7/1/97-001-R for removals). Reports received without a seven digit registration number will be assigned a seven digit central file number by the district office reviewing the reports.

(2) The name, address, and telephone number of the manufacturer or importer, and the name, title, address, and telephone number of the manufacturer or importer representative responsible for conducting the device correction or removal.

(3) The brand name and the common name, classification name, or usual name of the device and the intended use of the device.

(4) Marketing status of the device, i.e., any applicable premarket notification number, premarket approval number, or indication that the device is a preamendments device, and the device listing number. A manufacturer or importer that does not have an FDA establishment registration number shall indicate in the report whether it has ever registered with FDA.

(5) The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.

(6) The manufacturer's name, address, telephone number, and contact person if different from that of the person submitting the report.

(7) A description of the event(s) giving rise to the information reported and the corrective or removal actions that have been, and are expected to be taken.

(8) Any illness or injuries that have occurred with use of the device. If applicable, include the medical device report numbers.

(9) The total number of devices manufactured or distributed subject to the correction or removal and the number in the same batch, lot, or equivalent unit of production subject to the correction or removal.

(10) The date of manufacture or distribution and the device's expiration date or expected life.

(11) The names, addresses, and telephone numbers of all domestic and foreign consignees of the device and the dates and number of devices distributed to each such consignee.

(12) A copy of all communications regarding the correction or removal and the names and addresses of all recipients of the communications not provided in accordance with paragraph (c)(11) of this section.

(13) If any required information is not immediately available, a statement as to why it is not available and when it will be submitted.

(d) If, after submitting a report under this part, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer shall within 10-working days of initiating the extension of the correction or removal, amend the report by submitting an amendment citing the original report number assigned according to paragraph (c)(1) of this section, all of the information required by paragraph (c)(2), and any information required by paragraphs (c)(3) through (c)(12) of this section that is different from the information submitted in the original report. The manufacturer or importer shall also provide a statement in accordance with paragraph (c)(13) of this section for any required information that is not readily available.

(e) A report submitted by a manufacturer or importer under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the manufacturer, importer, or FDA that the report or information constitutes an admission that the device caused or contributed to a death or serious injury. A manufacturer or importer need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the device caused or contributed to a death or serious injury.

(f) No report of a correction or removal is required under this part, if a report of the correction or removal is

required and has been submitted under parts 803, 804, or 1004 of this chapter.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]

§ 806.20 Records of corrections and removals not required to be reported. (a) Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under §806.10 shall keep a record of such correction or removal.

(b) Records of corrections and removals not required to be reported to FDA under §806.10 shall contain the following information:

(1) The brand name, common or usual name, classification, name and product code if known, and the intended use of the device.

(2) The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.

(3) A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.

(4) Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any followups, and be reviewed and evaluated by a designated person.

(5) A copy of all communications regarding the correction or removal.

(c) The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained under paragraph (b) of this section must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]

§ 806.30 FDA access to records.

Each device manufacturer or importer required under this part to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or em

ployee designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports. [63 FR 42233, Aug. 7, 1998]

§ 806.40 Public availability of reports.

(a) Any report submitted under this part is available for public disclosure in accordance with part 20 of this chapter.

(b) Before public disclosure of a report, FDA will delete from the report:

(1) Any information that constitutes trade secret or confidential commercial or financial information under § 20.61 of this chapter; and

(2) Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy under §20.63 of this chapter or 5 U.S.C. 552(b)(6); provided, that except for the information under § 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

807.39 Misbranding by reference to establishment registration or to registration number.

Subpart C-Registration Procedures for

Foreign Device Establishments

807.40 Establishment registration and device listing for U.S. agents of 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 submission is required.

807.85 Exemption from premarket notification.

807.87 Information required in a premarket notification submission.

807.90 Format of a premarket notification submission.

807.92 Content and format of a 510(k) sum

mary.

807.93 Content and format of a 510(k) state

ment.

807.94 Format of class III certification. 807.95 Confidentiality of information.

807.97 Misbranding by reference to pre

market notification.

807.100 FDA action on a premarket notification.

AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 3601, 360j, 371, 374.

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 offered 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 intended for human use which has in effect an approved exemption for investigational 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 interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under 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 premarket 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, propagation, compounding, assembly, or processing of a device means the making by chemical, physical, biological, 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 changing 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 importation of devices manufactured in foreign establishments; or

(3) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications.

(e) Official correspondent means the person designated by the owner or operator of an establishment as responsible 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;

(4) The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm's establishments; and

(5) The annual certification of medical device reports required by §804.30

of this chapter or forwarding the certification form to the person designated by the firm as responsible for the certification.

(f) Owner or operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.

(g) Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, 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 written or oral authorization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Commissioner may prescribe.

(j) Classification name means the term used by the Food and Drug Administration and its classification panels to describe a device or class of devices for purposes of classifying devices under section 513 of the act.

(k) Representative sampling of advertisements means typical advertising material that gives the promotional 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 include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include 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.

(n) 510(k) summary (summary of any information respecting safety and effectiveness) means a summary, submitted under section 513(i) of the act, of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.

(0) 510(k) statement means a statement, made under section 513(i) of the act, asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in §20.61 of this chapter.

(p) Class III certification means a certification that the submitter of the 510(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.

(q) Class III summary means a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.

(r) U.S.-designated agent means the person, residing in the United States, designated and authorized by the owner or operator of a foreign manufacturer who exports devices into the United States and is responsible for:

(4) Submitting registration information,

(5) Submitting device listing information, and

(6) Submitting premarket notifications on behalf of the foreign manufacturer.

(s) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]

EFFECTIVE DATE NOTE: At 61 FR 38347, July 23, 1996, in §807.3, paragraph (r) was stayed indefinitely.

Subpart B-Procedures for Domestic Device Establishments

§ 807.20 Who must register and submit a device list.

(a) An owner or operator of an establishment not exempt under section 510(g) of the act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is required to register and to submit listing information for those devices in commercial distribution, except that listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations 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 products and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act. An owner or operator is required 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 interstate commerce. The registration and listing requirements shall pertain to any person who:

(1) Initiates or develops specifications for a device that is to be manufactured by a second party for commercial distribution by the person initiating specifications;

(2) Manufactures for commercial distribution a device either for itself or for another person. However, a person who only manufactures devices according to another person's specifications, for commercial distribution by the person initiating specifications, is not required to list those devices.

(3) Repackages or relabels a device; (4) Acts as an initial importer;

(5) Manufactures components or accessories which are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g., blood filters, 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.

(6) Acts as the U.S.-designated agent as defined in § 807.3(r).

(b) No registration or listing fee is required. Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of section 201(h) of the act.

(c) Registration and listing requirements shall not pertain to any person who:

(1) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;

(2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the devices.

(3) Acts as a wholesale distributor, as defined in §807.3(s), and who does not manufacture, repackage, process, or relabel a device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]