Investigational Device Exemptions Reports and Records - 21 CFR 812

OMB 0910-0078

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 Reports and Records - 21 CFR 812 expires 2022-11-30 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Justification for No Material/Nonsubstantive Change
Supporting Statement A
All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-12-18
Improperly submitted and continue
No material or nonsubstantive change to a currently approved collection 2019-12-16
Approved without change
Extension without change of a currently approved collection 2019-10-07
Approved without change
Extension without change of a currently approved collection 2016-03-22
Approved without change
Extension without change of a currently approved collection 2013-01-03
Approved without change
No material or nonsubstantive change to a currently approved collection 2012-12-17
Withdrawn and continue
Extension without change of a currently approved collection 2012-12-03
Approved without change
Extension without change of a currently approved collection 2010-01-29
Approved without change
Extension without change of a currently approved collection 2006-11-15
Approved without change
Extension without change of a currently approved collection 2003-07-02
Approved without change
Extension without change of a currently approved collection 2000-07-05
Approved without change
Reinstatement without change of a previously approved collection 1997-07-18
Approved without change
Reinstatement with change of a previously approved collection 1993-03-04
Approved without change
Reinstatement with change of a previously approved collection 1988-11-07
Approved without change
Revision of a currently approved collection 1985-08-23
Approved without change
Revision of a currently approved collection 1982-06-22
Approved without change
New collection (Request for a new OMB Control Number) 1980-04-29
OMB Details

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Federal Enterprise Architecture: Health - Consumer Health and Safety


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