Investigational Device Exemptions

OMB 0910-0078

The Food and Drug Administration (FDA) is requesting approval from the Office of Management and Budget (OMB) for information collection requirements contained in 21 CFR, Part 812. The IDE regulation permits a device to be shipped in interstate commerce for clinical investigation to determine its medical safety and effectiveness. Although the IDE regulations exempts the device from certain requirements of the Act, it requires safeguards for humans who are subjects of investigations; maintenance of sound ethical standards; and procedures to assure development of reliable scientific data.

The latest form for Investigational Device Exemptions expires 2022-11-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0078 IDEs SSA 2022 Rev.docx Supporting Statement A
0078 Change Request to include 0741 MAY 2021.docx Justification for No Material/Nonsubstantive Change
0078--change request--moving OUS to 0078--05-06-21.pdf Justification for No Material/Nonsubstantive Change
IDE Reporting (including reports for nonsignificant studies)
Third Party Disclosures
IDE Recordkeeping

All Historical Document Collections

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201212-0910-001 Withdrawn and continue	Extension without change of a currently approved collection	2012-12-03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

Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety