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

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§ 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) Product model, catalog, serial and lot number;
(v) A brief description of the event reported to the manufacturer and/or us; and
(vi) 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.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 803 after this date.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803