OMB control number

Medical Device Reporting

OMB 0910-0437 · HHS/FDA.

OMB 0910-0437

This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

The latest form for Medical Device Reporting expires 2029-02-28 and is listed under ICR 202412-0910-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Reporting; Manufacturer Reporting-- 803.50 through 803.53	Information collection
Postmarketing Safety Reporting for Combination Products	Information collection
Reporting: Special controls: submission of complaint log; 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii)	Information collection
Reporting; Voluntary Malfunction Summary Reporting Program	Information collection
Disclosure; Importer Reporting, Death and Serious Injury	Information collection
Recordkeeping; MDR Files--803.18	Information collection
Recordkeeping; MDR Procedures--803.17	Information collection
Reporting; Supplemental Reports--803.56	Information collection
Reporting; Importer Reporting, Death and Serious Injury--803.40 and 803.42	Information collection
Reporting; User Facility Annual Reporting--803.33; FDA Form 3419	Information collection
Reporting; User Facility Reporting-- 803.30 and 803.32	Information collection
Reporting; Exemptions--803.19	Information collection

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202412-0910-004	Reinstatement with change of a previously approved collection	2025-07-30
202303-0910-015	No material or nonsubstantive change to a currently approved collection	2023-03-20	Approved without change
202202-0910-015	Revision of a currently approved collection	2022-02-22	Approved without change
202107-0910-003	Extension without change of a currently approved collection	2021-07-29	Approved without change
201805-0910-006	Revision of a currently approved collection	2018-06-21	Approved with change
201508-0910-002	Extension without change of a currently approved collection	2015-08-31	Approved without change
201507-0910-011	Revision of a currently approved collection	2015-08-03	Approved without change
201206-0910-003	Extension without change of a currently approved collection	2012-06-08	Approved without change
200909-0910-006	Revision of a currently approved collection	2009-09-17	Comment filed on proposed rule and continue
200905-0910-004	Extension without change of a currently approved collection	2009-05-28	Approved without change
200603-0910-011	Extension without change of a currently approved collection	2006-03-31	Approved without change
200302-0910-002	Extension without change of a currently approved collection	2003-02-13	Approved without change
200001-0910-003	New collection (Request for a new OMB Control Number)	2000-01-28	Approved without change

OMB Details

Reporting; Manufacturer Reporting-- 803.50 through 803.53

Federal Enterprise Architecture: Health - Consumer Health and Safety