Administrative Detention and Banned Medical Devices

OMB 0910-0114

OMB 0910-0114

The FDA has the statutory authority under section 304(g) of the FD&C Act to detain devices during establishment inspections which are believed to be adulturated or misbranded. On March 9, 1979, FDA issued a final regulation on Administrative Detention Procedures which includes, among other things, certain reporting and recordkeeping requirements. FDA also has the statutory authority under section 516 of the Act to ban devices that present substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals. Under these authorities there are requirements pertaining to reporting and recordkeeping activities that are necessary in order for the Agency to carry out its mission to protect the public health.

The latest form for Administrative Detention and Banned Medical Devices expires 2022-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
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Extension without change of a currently approved collection 2019-05-02
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Extension without change of a currently approved collection 2016-04-11
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Extension without change of a currently approved collection 2013-02-08
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Extension without change of a currently approved collection 2010-01-29
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Extension without change of a currently approved collection 2006-11-15
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Extension without change of a currently approved collection 2003-06-30
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Extension without change of a currently approved collection 2000-07-07
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-09-13
Approved without change
Reinstatement without change of a previously approved collection 1997-07-18
Approved without change
No material or nonsubstantive change to a currently approved collection 1995-09-30
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Reinstatement with change of a previously approved collection 1992-09-02
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Reinstatement with change of a previously approved collection 1988-09-08
Approved without change
Revision of a currently approved collection 1985-07-03
Approved without change
Extension without change of a currently approved collection 1982-12-23
Approved without change
New collection (Request for a new OMB Control Number) 1980-11-19

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