[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.33]

[Page 55]
 
                        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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