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.

All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2023-06-21
Approved without change
Revision of a currently approved collection 2022-05-23
Approved without change
Extension without change of a currently approved collection 2021-11-22
Approved with change
Revision of a currently approved collection 2018-09-25
Approved without change
Revision of a currently approved collection 2015-06-11
Approved with change
Revision of a currently approved collection 2012-06-28
Withdrawn and continue
Revision of a currently approved collection 2011-12-08
Approved without change
Extension without change of a currently approved collection 2008-10-09
Approved without change
Revision of a currently approved collection 2005-08-26
Approved with change
Extension without change of a currently approved collection 2003-06-25
Approved without change
Extension without change of a currently approved collection 2000-11-16
Approved without change
Extension without change of a currently approved collection 1999-09-07
Approved without change
Reinstatement with change of a previously approved collection 1998-06-03
Approved without change
No material or nonsubstantive change to a currently approved collection 1995-09-30
Approved without change
Revision of a currently approved collection 1994-10-27
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 3500MedWatch Fillable FileableForm

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


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