Premarket Approval of Medical Devices - 21 CFR Part 814

OMB 0910-0231

OMB 0910-0231

This ICR collects information from persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. The PMA regulation establishes procedures that FDA utilizes in approving, denying, or withdrawing approval of any PMA. It provides specific, clear, and flexible instructions to applicants so those respondents know what information is required in a PMA. PMA supplements are also used by FDA to determine any additional action the agency must take to protect the public health. The data reported to FDA and the records that are maintained allow FDA and industry to make decisions and take actions to protect the public health from defective medical devices.

The latest form for Premarket Approval of Medical Devices - 21 CFR Part 814 expires 2023-03-31 and can be found here.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2020-03-20
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-12-16
Approved without change
Extension without change of a currently approved collection 2017-01-31
Approved without change
No material or nonsubstantive change to a currently approved collection 2016-01-12
Withdrawn and continue
No material or nonsubstantive change to a currently approved collection 2015-05-04
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-01-26
Approved with change
No material or nonsubstantive change to a currently approved collection 2014-10-17
Approved without change
Extension without change of a currently approved collection 2013-11-22
Approved without change
No material or nonsubstantive change to a currently approved collection 2013-11-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2012-12-12
Approved without change
Extension without change of a currently approved collection 2010-10-15
Approved without change
Extension without change of a currently approved collection 2007-09-27
Approved without change
Extension without change of a currently approved collection 2004-07-14
Approved without change
Extension without change of a currently approved collection 2001-05-18
Approved without change
Reinstatement without change of a previously approved collection 1999-05-06
Withdrawn and continue
Extension without change of a currently approved collection 1999-02-03
Approved without change
Reinstatement without change of a previously approved collection 1997-10-24
Approved without change
Revision of a currently approved collection 1993-09-03
Approved without change
Reinstatement with change of a previously approved collection 1990-04-13
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-06-13
Approved without change
New collection (Request for a new OMB Control Number) 1986-07-23
OMB Details

Premarket Approval of Medical Devices Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety


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