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Electronic Code of Federal Regulations

e-CFR Data is current as of April 22, 2014

Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart C—User Facility Reporting Requirements


§803.33   If I am a user facility, what must I include when I submit an annual report?

(a) You must submit to us an annual report on FDA Form 3419, or electronic equivalent as approved by us under §803.14. You must submit an annual report by January 1, of each year. You must clearly identify your annual report as such. Your annual report must include:

(1) Your CMS provider number used for medical device reports, or the number assigned by us for reporting purposes in accordance with §803.3;

(2) Reporting year;

(3) Your name and complete address;

(4) Total number of reports attached or summarized;

(5) Date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period (e.g., 1234567890-2004-0001 through 1000);

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

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

(i) Report number;

(ii) Name and address of the device manufacturer;

(iii) Device brand name and common name;

(iv) The unique device identifier (UDI) that appears on the device label or on the device package;

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

(vi) A brief description of the event reported to the manufacturer and/or us; and

(vii) Where the report was submitted, i.e., to the manufacturer, importer, or us.

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

(c) If you did not submit any medical device reports to manufacturers or us during the time period, you do not need to submit an annual report.

[70 FR 9519, July 13, 2005, as amended at 78 FR 55820, Sept. 24, 2013]



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