FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)

This information collection supports implementation of FDA's adverse event reporting programs, including voluntary reports as well as reports utilizing paper-based submission. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA.

The latest form for FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection) expires 2027-09-30 and can be found here.

CBER/CDER Form FDA 3500

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.