OMB control number

FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)

OMB 0910-0291 · HHS/FDA.

OMB 0910-0291

This information collection supports implementation of FDA's adverse event reporting programs, including voluntary reports as well as reports utilizing paper-based submission. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA.

The latest form for FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection) expires 2027-09-30 and is listed under ICR 202603-0910-005.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
CBER, Form FDA 3500A	Instruction
Submissions via SRP, including voluntary submissions	Other-Unified Intake Tool
Written Request for temporary waiver of mandatory electronic reporting	Information collection
CBER/CDER Form FDA 3500B	Form and Instruction
CTP Form FDA 3500	Information collection
HFP Form FDA 3500A	Other-Agency Guidance
HFP Form FDA 3500	Form and Instruction
CDRH Forms FDA 3500, FDA 3500B	Form and Instruction
CBER/CDER Form FDA 3500	Form

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202603-0910-005	No material or nonsubstantive change to a currently approved collection	2026-04-13
202411-0910-004	Revision of a currently approved collection	2025-06-25
202306-0910-006	No material or nonsubstantive change to a currently approved collection	2023-06-21	Approved without change
202205-0910-006	Revision of a currently approved collection	2022-05-23	Approved without change
202110-0910-001	Extension without change of a currently approved collection	2021-11-22	Approved without change
201807-0910-001	Revision of a currently approved collection	2018-09-25	Approved with change
201505-0910-002	Revision of a currently approved collection	2015-06-11	Approved without change
201206-0910-012	Revision of a currently approved collection	2012-06-28	Approved with change
201112-0910-001	Revision of a currently approved collection	2011-12-08	Withdrawn and continue
200810-0910-003	Extension without change of a currently approved collection	2008-10-09	Approved without change
200508-0910-004	Revision of a currently approved collection	2005-08-26	Approved without change
200306-0910-004	Extension without change of a currently approved collection	2003-06-25	Approved with change
200011-0910-004	Extension without change of a currently approved collection	2000-11-16	Approved without change
199909-0910-001	Extension without change of a currently approved collection	1999-09-07	Approved without change
199806-0910-001	Reinstatement with change of a previously approved collection	1998-06-03	Approved without change
199509-0910-018	No material or nonsubstantive change to a currently approved collection	1995-09-30	Approved without change
199410-0910-003	Revision of a currently approved collection	1994-10-27	Approved without change
199304-0910-001	New collection (Request for a new OMB Control Number)	1993-04-20	Approved without change

OMB Details

CBER/CDER Form FDA 3500

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
Form 3500	MedWatch	Fillable Fileable	Form

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