[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.33]



[Page 50]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                          SERVICES (CONTINUED)

 

PART 803_MEDICAL DEVICE REPORTING--Table of Contents

 

             Subpart C_User Facility Reporting Requirements

 

Sec.  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 Sec.  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 Sec.  

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 Sec.  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.



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