MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

OMB 0910-0291

OMB 0910-0291

This information collection covers paper-based reporting under FDA's MedWatch safety reporting program. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA - both voluntarily and as prescribed in agency regulations.

The latest form for MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based) expires 2021-11-30 and can be found here.

OMB Details

Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3500MedWatch Fillable FileableForm

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


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