Information Collection Request

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

ICR 202306-0910-006 · OMB 0910-0291 · Active

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0291 can be found here:

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Status
253752	Electronic Submissions of Voluntary Submissions including via SRP	Unchanged
253750	Electronic Submissions via ESG - Mandatory Reports	Unchanged
233178	Written Request for temporary waiver of mandatory electronic reporting	Unchanged
216812	All Centers - Form 3500B (Consumer Reporting)	Unchanged
216808	Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Unchanged
216806	Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)	Unchanged
216802	Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Unchanged
216800	Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)	Unchanged
216796	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)	Unchanged

ICR Details

Status	Active
Agency/Subagency	HHS/FDA
OMB Control No	0910-0291
Type of Information Collection	No material or nonsubstantive change to a currently approved collection
Previous ICR Reference No	202205-0910-006
Agency Tracking No	CROSS CENTER
Date Submitted to OIRA	2023-06-21
Requested Expiration Date	1969-12-31