(ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

(iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;

(3) Date of event;

(4) Date of report by the initial reporter;

(5) Description of the event or problem to include a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event;

(6) Description of relevant tests, including dates and laboratory data; and

(7) Other relevant patient history including pre-existing medical conditions.

(c) Device information (Block D) shall contain the following:

(1) Brand name;

(2) Type of device;

(3) Manufacturer name and address; (4) Operator of the device (health professional, patient, lay user, other);

(5) Expiration date;

(6) Model number, catalog number, serial number, lot number or other identifying number;

(7) Date of device implantation (month, day, year);

(8) Date of device explantation (month, day, year);

(9) Whether the device was available for evaluation, and whether the device was returned to the manufacturer, and if so, the date it was returned to the manufacturer; and

(10) Concomitant medical products and therapy dates. (Do not list products that were used to treat the event.)

(d) Initial reporter information (Block E) shall contain the following:

(1) Name, address, and phone number of the reporter who initially provided information to the user facility, manufacturer, or distributor;

(2) Whether the initial reporter is a health professional;

(3) Occupation; and

(4) Whether the initial reporter also sent a copy of the report to FDA, if known.

(e) All manufacturers (Block G) shall contain the following:

(1) Contact office name and address and device manufacturing site;

(2) Telephone number;

(3) Report sources;

(4) Date received by manufacturer (month, day, year);

(5) Type of report being submitted (e.g., 5-day, initial, supplemental); and (6) Manufacturer report number.

(f) Device manufacturers (Block H) shall contain the following:

(1) Type of reportable event (death, serious injury, malfunction, etc.);

(2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc.);

(3) If the device was returned to the manufacturer and evaluated by the manufacturer, a summary of the evaluation. If no evaluation was performed, provide an explanation why no evaluation was performed;

(4) Device manufacture date (month, day, year);

(5) Was device labeled for single use; (6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA "Coding Manual for Form 3500A"); (7) Whether remedial action taken and type;

was

(8) Whether use of device was initial, reuse, or unknown;

(9) Whether remedial action was reported as a removal or correction under section 519(f) of the act (list the correction/removal report number); and (10) Additional manufacturer narrative; and/or

(11) Corrected data, including:

(i) Any information missing on the user facility report or distributor report, including missing event codes, or information corrected on such forms after manufacturer verification;

(ii) For each event code provided by the user facility under §803.32(d)(10) or a distributor, a statement of whether the type of the event represented by the code is addressed in the device labeling; and

(iii) If any required information was not provided, an explanation of why such information was not provided and the steps taken to obtain such information.

§ 803.53 Five-day reports.

A manufacturer shall submit a 5-day report to FDA, on Form 3500A or electronic equivalent as approved by FDA under § 803.14 within 5 workdays of:

(a) Becoming aware that a reportable MDR event or events, from any information, including any trend analysis, necessitates remedial action to prevent

an

unreasonable risk of substantial harm to the public health; or

(b) Becoming aware of an MDR reportable event for which FDA has made a written request for the submission of a 5-day report. When such a request is made, the manufacturer shall submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. The time period stated in the original written request can be extended by FDA if it is in the interest of the public health.

§803.55 Baseline reports.

(a) A manufacturer shall submit a baseline report on FDA Form 3417, or electronic equivalent as approved by FDA under §803.14 for a device when the device model is first reported under § 803.50.

(b) Each baseline report shall be updated annually, on the anniversary month of the initial submission, after the initial baseline report is submitted. Changes to baseline information shall be reported in the manner described in § 803.56 (i.e., include only the new, changed, or corrected information in the appropriate portion(s) of the report form). Baseline reports shall contain the following:

(1) Name, complete address, and registration number of the manufacturer's reporting site. If the reporting site is not registered, FDA will assign a temporary registration number until the reporting site officially registers. The manufacturer will be informed of the temporary registration number;

(2) FDA registration number of each site where the device is manufactured;

(3) Name, complete address, and telephone number of the individual who has been designated by the manufacturer as its MDR contact and date of the report. For foreign manufacturers,

a confirmation that the individual submitting the report is the agent of the manufacturer designated under § 803.58(a) is required;

(4) Product identification, including device family, brand name, generic name, model number, catalog number, product code and any other product identification number or designation;

(5) Identification of any device previously reported in a baseline report that is substantially similar (e.g., same device with a different model number, or same device except for cosmetic differences in color or shape) to the device being reported, including the identification of the previously reported device by model number, catalog number or other product identification, and the date of the baseline report for the previously reported device;

(6) Basis for marketing, including 510(k) premarket notification number or PMA number, if applicable, and whether the device is currently the subject of an approved post-market study under section 522 of the act;

(7) Date the device was initially marketed and, if applicable, the date on which the manufacturer ceased marketing the device;

(8) Shelf life, if applicable, and expected life of the device;

(9) The number of devices manufactured and distributed in the last 12 months and, an estimate of the number of devices in current use; and

(10) Brief description of any methods used to estimate the number of devices distributed and the method used to estimate the number of devices in current use. If this information was provided in a previous baseline report, in lieu of resubmitting the information, it may be referenced by providing the date and product identification for the previous baseline report.

EFFECTIVE DATE NOTE: At 61 FR 39869, July 31, 1996, in §803.55, paragraphs (b)(9) and (10) were stayed indefinitely.

§803.56 Supplemental reports.

When a manufacturer obtains information required under this part that was not provided because it was not known or was not available when the initial report was submitted, the manufacturer shall submit to FDA the supplemental information within 1 month

following receipt of such information. In supplemental reports, the manufacturer shall:

(a) Indicate on the form and the envelope, that the reporting form being submitted is a supplemental report. If the report being supplemented is an FDA Form 3500A report, the manufacturer must select, in Item H-2, the appropriate code for the type of supplemental information being submitted;

(b) Provide the appropriate identification numbers of the report that will be updated with the supplemental information, e.g., original manufacturer report number and user facility report number, if applicable;

(c) For reports that cross reference previous reports, include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s).

§ 803.58 Foreign manufacturers.

(a) Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of this regulation, foreign manufacturers shall inform FDA, by letter, of the name and address of the U.S. agent designated under this section and §807.40 of this chapter, and shall update this information as necessary. Such updated information shall be submitted to FDA, within 5 days of a change in the designated agent information.

(b) U.S.-designated agents of foreign manufacturers are required to:

(1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, 803.55, and 803.56; (2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of § 803.50;

(3) Certify in accordance with § 803.57; (4) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement; (5) Maintain complaint files in accordance with § 803.18; and

SOURCE: 62 FR 27191, May 19, 1997, unless otherwise noted.

Subpart A-General Provisions §806.1 Scope.

(a) This part implements the provisions of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.

(b) The following actions are exempt from the reporting requirements of this part:

(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

(2) Market withdrawals as defined in § 806.2(h).

(3) Routine servicing as defined in § 806.2(k).

(4) Stock recoveries as defined in § 806.2(1).

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998] 8806.2 Definitions.

As used in this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) Agency or FDA means the Food and Drug Administration.

(c) Consignee means any person or firm that has received, purchased, or used a device subject to correction or removal.

(d) Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

(e) Correction or removal report number means the number that uniquely identifies each report submitted.

(f) Importer means, for the purposes of this part, any person who imports a device into the United States.

(g) Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device 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 user or consumer;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or

(3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.

(h) Market withdrawal means a correction or removal of a distributed deIvice that involves a minor violation of the act that would not be subject to legal action by FDA or that involves

no violation of the act, e.g., normal stock rotation practices.

(i) Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

(j) Risk to health means

(1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or

(2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

(k) Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

of

(1) Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.

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

Subpart B-Reports and Records §806.10 Reports of corrections and removals.

(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

(1) To reduce a risk to health posed by the device; or

(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as

set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under § 806.1(b).

(b) The manufacturer or importer shall submit any report required by paragraph (a) of this section within 10working days of initiating such correction or removal.

(c) The manufacturer or importer shall include the following information in the report:

(1) The seven digit registration number of the entity responsible for submission of the report of corrective or removal action (if applicable), the month, day, and year that the report is made, and a sequence number (i.e., 001 for the first report, 002 for the second report, 003 etc.), and the report type designation "C" or "R". For example, the complete number for the first correction report submitted on June 1, 1997, will appear as follows for a firm with the registration number 1234567: 1234567-6/1/97-001-C. The second correction report number submitted by the same firm on July 1, 1997, would be 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 es

tablishment 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