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 2029-06-30 and is listed under ICR 202505-0910-005.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0910-0449_Supporting Statement A_2025.docxSupporting Statement A
Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports Information collection
Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202505-0910-005 Extension without change of a currently approved collection 2025-12-23
202203-0910-007 Extension without change of a currently approved collection 2022-11-22 Approved without change
201909-0910-007 Extension without change of a currently approved collection 2019-10-29 Approved without change
201608-0910-014 Extension without change of a currently approved collection 2016-09-09 Approved without change
201309-0910-003 Extension without change of a currently approved collection 2013-09-12 Approved without change
201004-0910-007 Extension without change of a currently approved collection 2010-04-26 Approved without change
200703-0910-004 Extension without change of a currently approved collection 2007-03-08 Approved without change
200310-0910-010 Extension without change of a currently approved collection 2003-10-27 Approved without change
200008-0910-005 New collection (Request for a new OMB Control Number) 2000-08-29 Approved without change

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety