OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Medical Devices; Quality System Regulation Amendments: FINAL RULE

OMB 0910-0073 ยท HHS/FDA.

OMB 0910-0073

This information collection request supports FDA rulemaking. We are issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries).

The latest form for Medical Devices; Quality System Regulation Amendments: FINAL RULE expires 2027-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
Supplementary Document
All Historical Document Collections
 Revision of a currently approved collection 2024-03-20
Approved without change
 Extension without change of a currently approved collection 2022-12-19
Comment filed on proposed rule and continue
 Revision of a currently approved collection 2022-02-22
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
OMB Details

Quality System Regulation Amendments

Federal Enterprise Architecture: Health - Consumer Health and Safety