Reclassification Petitions for Medical Devices

OMB 0910-0138

OMB 0910-0138

This ICR collects information from medical device manufactures who wish to request reclassification of a medical device. A manufacturer may petition the Agency to reclassify a device. The reclassification procedures regulation requires a manufacturer to submit specific data when petitioning for reclassification. This includes both a "supplemental data sheet" (Form FDA 3427) and a "classification questionnaire" (Form FDA 3429). Each of these forms contains a series of questions concerning the safety and effectiveness of the device type. The regulation requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.

The latest form for Reclassification Petitions for Medical Devices expires 2022-02-28 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
Approved with change
Revision of a currently approved collection 2019-01-30
Approved without change
Extension without change of a currently approved collection 2018-08-20
Approved without change
Extension without change of a currently approved collection 2015-06-16
Approved without change
No material or nonsubstantive change to a currently approved collection 2012-07-26
Approved with change
Extension without change of a currently approved collection 2012-03-29
Approved without change
Extension without change of a currently approved collection 2009-03-27
Approved without change
Extension without change of a currently approved collection 2005-12-22
Approved without change
Extension without change of a currently approved collection 2002-11-08
Approved without change
Extension without change of a currently approved collection 1999-12-07
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 1996-12-11
Approved without change
Reinstatement with change of a previously approved collection 1991-03-29
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-05-02
Approved without change
Extension without change of a currently approved collection 1987-05-05
Approved without change
Reinstatement with change of a previously approved collection 1985-11-13
Approved without change
Reinstatement with change of a previously approved collection 1984-08-06
Approved with change
No material or nonsubstantive change to a currently approved collection 1984-01-04
Approved without change
Revision of a currently approved collection 1982-12-27
Approved without change
New collection (Request for a new OMB Control Number) 1981-10-30

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