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

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.

Latest Forms, Documents, and Supporting Material

Document Name
Electronic Submissions of Voluntary Submissions including via SRP
Electronic Submissions via ESG - Mandatory Reports
Written Request for temporary waiver of mandatory electronic reporting
All Centers - Form 3500B (Consumer Reporting)
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
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)

All Historical Document Collections

202306-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-06-21
202205-0910-006 Approved without change	Revision of a currently approved collection	2022-05-23
202110-0910-001 Approved without change	Extension without change of a currently approved collection	2021-11-22
201807-0910-001 Approved with change	Revision of a currently approved collection	2018-09-25
201505-0910-002 Approved without change	Revision of a currently approved collection	2015-06-11
201206-0910-012 Approved with change	Revision of a currently approved collection	2012-06-28
201112-0910-001 Withdrawn and continue	Revision of a currently approved collection	2011-12-08
200810-0910-003 Approved without change	Extension without change of a currently approved collection	2008-10-09
200508-0910-004 Approved without change	Revision of a currently approved collection	2005-08-26
200306-0910-004 Approved with change	Extension without change of a currently approved collection	2003-06-25
200011-0910-004 Approved without change	Extension without change of a currently approved collection	2000-11-16
199909-0910-001 Approved without change	Extension without change of a currently approved collection	1999-09-07
199806-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1998-06-03
199509-0910-018 Approved without change	No material or nonsubstantive change to a currently approved collection	1995-09-30
199410-0910-003 Approved without change	Revision of a currently approved collection	1994-10-27
199304-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1993-04-20

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 3500

MedWatch

Fillable Fileable

Form

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