OMB control number

Export of Medical Devices ; Foreign Letters of Approval

OMB 0910-0264 · HHS/FDA.

OMB 0910-0264

This information collection supports requests for foreign letters of approval to facilitate the export of FDA-regulated devices.

The latest form for Export of Medical Devices ; Foreign Letters of Approval expires 2029-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0910-0264_Supporting Statement_2025.docx Supporting Statement A
0910-0264_Supporting Statement_2025.docx Supporting Statement A
Export of Medical Devices; Foreign Letters of Approval

All Historical Document Collections

202503-0910-004	Extension without change of a currently approved collection	2025-09-11
202208-0910-016 Approved without change	Extension without change of a currently approved collection	2022-08-30
201907-0910-025 Approved without change	Extension without change of a currently approved collection	2019-07-30
201608-0910-002 Approved without change	Extension without change of a currently approved collection	2016-08-22
201307-0910-002 Approved without change	Extension without change of a currently approved collection	2013-07-11
201004-0910-005 Approved without change	Extension without change of a currently approved collection	2010-04-19
200702-0910-005 Approved without change	Extension without change of a currently approved collection	2007-02-20
200308-0910-002 Approved without change	Extension without change of a currently approved collection	2003-08-25
200009-0910-001 Approved without change	Extension without change of a currently approved collection	2000-09-08
199710-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1997-10-06
199305-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1993-05-05
198908-0910-003 Approved without change	New collection (Request for a new OMB Control Number)	1989-08-28