OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Postmarket Surveillance of Medical Devices

OMB 0910-0449 ยท HHS/FDA.

OMB 0910-0449

This information collection implements section 522 of the Federal Food, Drug, and Cosmetic Act, which governs the postmarket surveillance of medical devices. Respondents to the information collection are medical device manufacturers who must conduct surveillance in accordance with statutory orders issued by FDA in support of the clearance or approval of certain devices. The information collection is intended to ensure the continued safety of medical devices.

The latest form for Postmarket Surveillance of Medical Devices expires 2026-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
All Historical Document Collections
 Extension without change of a currently approved collection 2025-12-23
Approved without change
 Extension without change of a currently approved collection 2022-11-22
Approved without change
 Extension without change of a currently approved collection 2019-10-29
Approved without change
 Extension without change of a currently approved collection 2016-09-09
Approved without change
 Extension without change of a currently approved collection 2013-09-12
Approved without change
 Extension without change of a currently approved collection 2010-04-26
Approved without change
 Extension without change of a currently approved collection 2007-03-08
Approved without change
 Extension without change of a currently approved collection 2003-10-27
Approved without change
 New collection (Request for a new OMB Control Number) 2000-08-29
OMB Details

Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports

Federal Enterprise Architecture: Health - Consumer Health and Safety