OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Medical Devices; Device Tracking

OMB 0910-0442 ยท HHS/FDA.

OMB 0910-0442

This ICR collects information from device manufactures and distributors who are subject to the requirements for device tracking, tracking systems, and distributor reporting. Manufacturers must track a class II or class III device if its failure would be reasonable likely to have serious adverse health consequences, or it is intended to be implanted in the human body for more than one year, or it is life-sustaining or life-supporting and used outside a device user facility, or when FDA determines that tracking would be appropriate in order to protect the general public in the event of a device recall.

The latest form for Medical Devices; Device Tracking expires 2027-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
All Historical Document Collections
Approved without change
 Extension without change of a currently approved collection 2023-12-06
Approved with change
 Extension without change of a currently approved collection 2021-02-19
Approved without change
 Extension without change of a currently approved collection 2018-01-23
Approved with change
 Revision of a currently approved collection 2014-10-27
Approved with change
 Extension without change of a currently approved collection 2011-05-10
Approved with change
 Extension without change of a currently approved collection 2008-04-25
Approved without change
 Extension without change of a currently approved collection 2005-03-03
Approved without change
 Revision of a currently approved collection 2002-02-07
Approved without change
 Existing collection in use without an OMB Control Number 2000-04-18
OMB Details

Medical Device Tracking - Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety