[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
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  Annual reports.

    (a) Each user facility shall submit to FDA an annual report on FDA 
Form 3419, or electronic equivalent as approved by FDA under 
Sec. 803.14. Annual reports shall be submitted by January 1 of each 
year. The annual report and envelope shall be clearly identified and 
submitted to FDA with information that includes:
    (1) User facility's HCFA provider number used for medical device 
reports, or number assigned by FDA for reporting purposes in accordance 
with Sec. 803.3(ee);
    (2) Reporting year;
    (3) Facility's name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and the lowest and highest user 
facility report number of medical device reports submitted during the 
report period, e.g., 1234567890-1995-0001 through 1000;
    (6) Name, position title, and complete address of the individual 
designated as the facility contact person responsible for reporting to 
FDA and whether that person is a new contact for that facility; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:
    (i) User facility 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 FDA; and
    (vi) Where the report was submitted, i.e., to FDA, manufacturer, 
distributor, importer, etc.
    (b) In lieu of submitting the information in paragraph (a)(7) of 
this section, a user facility may submit a copy of FDA Form 3500A, or an 
electronic equivalent as approved under section 803.14, for each medical 
device report submitted to FDA and/or manufacturers by that facility 
during the reporting period.
    (c) If no reports are submitted to either FDA or manufacturers 
during these time periods, no annual report is required.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]