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Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA3419 |
Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA 3419
Under 21 CFR Part 803, the MDR regulation requires that user facilities submit an annual summary report to FDA of all reportable adverse events submitted to manufacturers or the FDA during a designated reporting period. The annual reports must be submitted by January 1 for reportable events that were filed in the previous calendar year, January 1 through December 31. An annual report is not required if there were no reportable events submitted during the applicable reporting period. The annual report must provide the following information:
PART 1
5a-b: Enter the lowest and the highest user facility report number submitted during the reporting period. The report numbers consist of the CMS or FDA provided number, the 4-digit calendar year in which the reports were submitted and the 4-digit sequence number assigned to the adverse event.
For each adverse event report listed in the range of numbers identified in items 5a and 5b, attach a photocopy of the completed MedWatch FDA Form 3500A or, alternatively, you may complete Part 2 of this form for each event.
PART 2
This section is only filled out for each reported adverse event, if a photocopy of the 3500A for the report is not attached.
The requirement for semiannual reporting by user facilities under 21 CFR Part 803.33 of the MDR regulation was changed to an annual report requirement by the Food and Drug Administration Modernization Act (FDAMA) dated November 21, 1997. The effective date of this change took place on February 19, 1998. (Reference Federal Register Notice dated May 12, 1998, docket number 98N-0170). |
Updated May 18, 1999
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