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 Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form from the following sources:

(1) On the Internet at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080796.pdf or

(2) Division of International and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: DICE@fda.hhs.gov, FAX: 301-847-8149, or telephone: 800-638-2041.

(b) You must clearly identify your annual report as such. You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. 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., 1234567890-2011-0001 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 and unique device identifier (UDI) that appears on the device label or on the device package;

(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.

(c) In lieu of submitting the information in paragraph (b)(7) of this section, you may submit a copy of each medical device report that you submitted to the manufacturers and/or to us during the reporting period.

(d) 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.

[ 79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

Title 21 published on 19-May-2018 03:57

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

  • 2018-01-16; vol. 83 # 10 - Tuesday, January 16, 2018
    1. 83 FR 2057 - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      The announcement of the guidance is published in the Federal Register on January 16, 2018.
      21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830
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