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(7) Type of report (initial or followup (if followup, include report number of initial report));

(8) Date of the user facility report (month, day, year);

(9) Approximate age of device;

(10) Event problem codes patient code and device code (refer to FDA "Coding Manual For Form 3500A”);

(11) Whether a report was sent to FDA and the date it was sent (month, day, year);

(12) Location, where event occurred;

(13) Whether report was sent to the manufacturer and the date it was sent (month, day, year); and

(14) Manufacturer name and address; if available.

(iv) Product model, catalog, serial and lot number;

(v) A brief description of the event reported to the manufacturer and/or FDA; and

(vi) Where the report was submitted, i.e., to FDA, manufacturer, distributor, importer, etc.

(b) In lieu of submitting the information in paragraph (a)(7) of this section, a user facility may submit a copy of FDA Form 3500A, an electronic equivalent as approved under section 803.14, for each medical device report submitted to FDA and/or manufacturers by that facility during the reporting period.

(c) If no reports are submitted to either FDA or manufacturers during these time periods, no annual report is required. [60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000)

or

Subpart D-Importer Reporting

Requirements

SOURCE: 65 FR 4120. Jan. 26. 2000, unless otherwise noted.

8803.33 Annual reports.

(a) Each user facility shall submit to FDA an annual report on FDA Form 3419, or electronic equivalent as approved by FDA under $803.14. Annual reports shall be submitted by January 1 of each year. The annual report and envelope shall be clearly identified and submitted to FDA with information that includes:

(1) User facility's HCFA provider number used for medical device reports, or number assigned by FDA for reporting purposes in accordance with $ 803.3(ee);

(2) Reporting year;

(3) Facility's name and complete address;

(4) Total number of reports attached or summarized;

(5) Date of the annual report and the lowest and highest user facility report number of medical device reports submitted during the report period, e.g., 1234567890–1995-0001 through 1000;

(6) Name, position title, and complete address of the individual designated as the facility contact person responsible for reporting to FDA and whether that person is a new contact for that facility; and

(7) Information for each reportable event that occurred during the annual reporting period including:

(i) User facility report number;

(ii) Name and address of the device manufacturer;

(iii) Device brand name and common name;

$ 803.40 Individual adverse event re

porting requirements; importers. (a) An importer shall submit to FDA a report, and a copy of such report to the manufacturer, containing the information required by $ 803.42 on FDA form 3500 A as soon as practicable, but not later than 30 days after the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury.

(b) An importer shall submit to the manufacturer a report containing information required by $ 803.42 on FDA form 3500A, as soon as practicable, but not later than 30 days after the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or through the importer's own research, testing, evaluation, servicing, or maintenance of one of its devices, that one of the devices marketed by the importer has malfunctioned and that such device or a similar device marketed by the importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. $ 803.42 Individual adverse event re

port data elements. Individual medical device importer reports shall contain the following information, in so far as the information is known or should be known to the importer, as described in $ 803.40, which corresponds to the format of FDA Form 3500A:

(a) Patient information (Block A) shall contain the following:

(1) Patient name or other identifier;

(2) Patient age at the time of event, or date of birth;

(3) Patient gender; and (4) Patient weight.

(b) Adverse event or product problem (Block B) shall contain the following:

(1) Adverse event or product problem;

(2) Outcomes attributed to the adverse event, that is:

(i) Death; (ii) Life threatening injury or illness;

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

(iv) 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 preexisting 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) Importer information (Block F) shall contain the following:

(1) Whether reporter is an importer; (2) Importer report number; (3) Importer address; (4) Contact person;

(5) Contact person's telephone number;

(6) Date the importer became aware of the event (month, day, yea

(7) Type of report (initial or followup (if followup, include report number of initial report));

(8) Date of the importer report (month, day, year);

(9) Approximate age of device; (10) Event problem codes

patient code and device code (refer to FDA "Coding Manual For Form 3500A");

(11) Whether a report was sent to FDA and the date it was sent (month, day, year);

(12) Location, where event occurred;

(13) Whether a report was sent to the manufacturer and the date it was sent (month, day, year); and

(14) Manufacturer name and address; if available.

Subpart E-Manufacturer

Reporting Requirements 8803.50 Individual adverse event re

ports; manufacturers. (a) Reporting standards. Device manufacturers are required to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device marketed by the manufacturer:

(1) May have caused or contributed to a death or serious injury; or

(2) Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.

(b) Information that is reasonably known to manufacturers. (1) Manufacturers must provide all information required in this subpart E that is reasonably known to them. FDA considers the following information to be reasonably known to the manufacturer:

(i) Any information that can be obtained by contacting a user facility, distributor and/or other initial reporter;

(ii) Any information in a manufacturer's possession; or

(iii) Any information that can be obtained by analysis, testing or other evaluation of the device.

(2) Manufacturers are responsible for obtaining and providing FDA with information that is incomplete or missing from reports submitted by user facilities, distributors, and other initial reporters. Manufacturers are also responsible for conducting an investigation of each event, and evaluating the cause of the event. If a manufacturer cannot provide complete information on an MDR report, it must provide a statement explaining why such information was incomplete and the steps taken to obtain the information. Any required information not available at the time of the report, which is obtained after the initial filing, must be provided by the manufacturer in a supplemental report under $803.56. 8803.52 Individual adverse event re

port data elements. Individual medical device manufacturer reports shall contain the fol

lowing information, known or reasonably known to them as described in 8803.50(b), which corresponds to the format of FDA Form 3500A:

(a) Patient information (Block A) shall contain the following:

(1) Patient name or other identifier;

(2) Patient age at the time of event, or date of birth;

(3) Patient gender; and (4) Patient weight.

(b) Adverse event or product problem (Block B) shall contain the following:

(1) Adverse event or product problem;

(2) Outcomes attributed to the adverse event, e.g., death; or serious injury, that is:

(i) Life threatening injury or illness;

(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.

(1) 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;

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

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

(10) Additional manufacturer rative; 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. 8 803.53 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.

was

8 803.55 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

a

nar

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 pro

vided 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. 8803.56 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.

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