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

ICR 202306-0910-006

OMB: 0910-0291

Federal Form Document

IC Document Collections

IC ID	Document Title	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