[U.S. Food and Drug Administration]

The FDA Medical Products Reporting Program

The Food and Drug Administration (FDA) announces the opportunity for public comment on the proposed revision of MedWatch Form FDA 3500 (voluntary) and MedWatch Form FDA 3500A (mandatory). These forms will be used to report to the agency on adverse events and product problems that occur with all medical products regulated by FDA.

Submit written comments on the collection of information by January 11, 1999.

Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request [Docket No. 96N-0393]

[Federal Register: November 10, 1998 (Volume 63, Number 217)][Notices][Pages 63064-63066]
Text Version, PDF Version

Proposed Revisions:

Summary of the Proposed Changes

Revised Voluntary Form 3500 , Currently Approved Voluntary Form 3500

Revised Mandatory Form 3500A , Curently Approved Mandatory Form 3500A

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