Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

OMB 0910-0073

OMB 0910-0073

This ICR collects information from medical device manufacturers who must meet the Current Good Manufacturing Practice Quality System (CGMP/QS) requirements for purchasing and service controls; recordkeeping requirements for device failure and complaint investigations; requirements for verifying/validating production processes and process or product changes; and requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/quality problems. CGMP/QS information collections assist FDA inspections of manufacturer compliance with quality system requirements encompassing design, production, installation, and servicing processes. Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production.

The latest form for Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation expires 2022-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
Improperly submitted and continue
No material or nonsubstantive change to a currently approved collection 2021-02-26
Approved without change
Extension without change of a currently approved collection 2019-11-15
Approved without change
Extension without change of a currently approved collection 2016-12-08
Approved without change
Extension without change of a currently approved collection 2013-12-19
Approved without change
Extension without change of a currently approved collection 2010-10-28
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 2004-07-08
Approved without change
Extension without change of a currently approved collection 2001-05-31
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-09-13
Approved without change
Reinstatement with change of a previously approved collection 1998-06-11
Approved without change
Reinstatement with change of a previously approved collection 1992-05-04
Approved without change
Revision of a currently approved collection 1988-08-04
Approved without change
Reinstatement with change of a previously approved collection 1985-06-14
Approved without change
Revision of a currently approved collection 1982-04-07
Approved without change
New collection (Request for a new OMB Control Number) 1980-03-06

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