OMB control number

Medical Devices; Quality System Regulation Amendments: FINAL RULE

OMB 0910-0073 · 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 is listed under ICR 202401-0910-008.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
0073 Quality System Reg Amendments CDRH Final Rule SSA AH99.docx	Supporting Statement A
0075 QSR FRIA 2024.pdf	Supplementary Document
Quality System Regulation Amendments	Information collection

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202401-0910-008	Revision of a currently approved collection	2024-03-20
202212-0910-004	Extension without change of a currently approved collection	2022-12-19	Approved without change
202202-0910-018	Revision of a currently approved collection	2022-02-22	Comment filed on proposed rule and continue
202102-0910-005	No material or nonsubstantive change to a currently approved collection	2021-02-26	Improperly submitted and continue
201911-0910-004	Extension without change of a currently approved collection	2019-11-15	Approved without change
201611-0910-002	Extension without change of a currently approved collection	2016-12-08	Approved without change
201312-0910-006	Extension without change of a currently approved collection	2013-12-19	Approved without change
201010-0910-006	Extension without change of a currently approved collection	2010-10-28	Approved without change
200709-0910-006	Extension without change of a currently approved collection	2007-09-27	Approved without change
200407-0910-003	Extension without change of a currently approved collection	2004-07-08	Approved without change
200105-0910-005	Extension without change of a currently approved collection	2001-05-31	Approved without change
199809-0910-010	No material or nonsubstantive change to a currently approved collection	1998-09-13	Approved without change
199806-0910-005	Reinstatement with change of a previously approved collection	1998-06-11	Approved without change
199205-0910-001	Reinstatement with change of a previously approved collection	1992-05-04	Approved without change
198808-0910-003	Revision of a currently approved collection	1988-08-04	Approved without change
198506-0910-003	Reinstatement with change of a previously approved collection	1985-06-14	Approved without change
198204-0910-004	Revision of a currently approved collection	1982-04-07	Approved without change
198003-0910-001	New collection (Request for a new OMB Control Number)	1980-03-06	Approved without change

OMB Details

Quality System Regulation Amendments

Federal Enterprise Architecture: Health - Consumer Health and Safety