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 is listed under ICR 202312-0910-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0442 Device Tracking SSA 2023 EXT.docxSupporting Statement A
Medical Device Tracking - Third-Party Disclosure Information collection
Medical Device Tracking - Recordkeeping Information collection
Medical Device Tracking - Reporting Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202312-0910-004 Extension without change of a currently approved collection 2023-12-06 Approved without change
202101-0910-009 Extension without change of a currently approved collection 2021-02-19 Approved with change
201801-0910-005 Extension without change of a currently approved collection 2018-01-23 Approved without change
201409-0910-021 Revision of a currently approved collection 2014-10-27 Approved with change
201105-0910-002 Extension without change of a currently approved collection 2011-05-10 Approved with change
200804-0910-007 Extension without change of a currently approved collection 2008-04-25 Approved with change
200503-0910-002 Extension without change of a currently approved collection 2005-03-03 Approved without change
200202-0910-002 Revision of a currently approved collection 2002-02-07 Approved without change
200004-0910-003 Existing collection in use without an OMB Control Number 2000-04-18 Approved without change

OMB Details

Medical Device Tracking - Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety