OMB control number

Investigational Device Exemptions

OMB 0910-0078 · HHS/FDA.

OMB 0910-0078

This information collection supports Food and Drug Administration (FDA, the agency, us or we) investigational device exemption (IDE) program. Respondents include private sector domestic and foreign medical device sponsors or applicants, including medical device manufacturers, investigators, hospitals, and other healthcare organizations.

The latest form for Investigational Device Exemptions expires 2026-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
IDE Reporting (including reports for nonsignificant studies) Other-Agency Guidance
IDE Recordkeeping Other-Agency Guidance

All Historical Document Collections

202505-0910-011	Extension without change of a currently approved collection	2026-02-27
202210-0910-013 Approved with change	Revision of a currently approved collection	2022-11-22
202104-0910-011 Approved with change	No material or nonsubstantive change to a currently approved collection	2021-05-19
201912-0910-007 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-12-18
201912-0910-004 Improperly submitted and continue	No material or nonsubstantive change to a currently approved collection	2019-12-16
201910-0910-002 Approved without change	Extension without change of a currently approved collection	2019-10-07
201603-0910-005 Approved without change	Extension without change of a currently approved collection	2016-03-22
201301-0910-001 Approved without change	Extension without change of a currently approved collection	2013-01-03
201212-0910-011 Approved without change	No material or nonsubstantive change to a currently approved collection	2012-12-17
201212-0910-001 Withdrawn and continue	Extension without change of a currently approved collection	2012-12-03
201001-0910-010 Approved without change	Extension without change of a currently approved collection	2010-01-29
200611-0910-001 Approved without change	Extension without change of a currently approved collection	2006-11-15
200307-0910-001 Approved without change	Extension without change of a currently approved collection	2003-07-02
200007-0910-001 Approved without change	Extension without change of a currently approved collection	2000-07-05
199707-0910-001 Approved without change	Reinstatement without change of a previously approved collection	1997-07-18
199303-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1993-03-04
198811-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1988-11-07
198508-0910-004 Approved without change	Revision of a currently approved collection	1985-08-23
198206-0910-004 Approved without change	Revision of a currently approved collection	1982-06-22
198004-0910-007 Approved without change	New collection (Request for a new OMB Control Number)	1980-04-29

OMB Details

IDE Reporting (including reports for nonsignificant studies)

Federal Enterprise Architecture: Health - Consumer Health and Safety