May 24, 2022· Comment from Consumer Healthcare Products Association· FDA-2021-N-0507-0063
Filed on regulations.gov — full text not in the inline record.
FDARulemakingFDA-2021-N-0507
Medical Devices; Quality System Regulation Amendments
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Last modified
Nov 4, 2024
Comment window
closed 1526d ago
Consumer Healthcare Products Association filings
1
Activity
Consumer Healthcare Products Association filed 1 comment on this docket between May 24, 2022 and May 24, 2022. 1 other organizations filed here. The comment window closed 1526d ago.
What Consumer Healthcare Products Association filed (1)
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation 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).
View on regulations.gov →Co-filers (1)
See everyone who commented →- Consumer Healthcare Products AssociationTHIS ORG1 filing · confidence 97%
- Advanced Medical Technology Associationtrade assoc.1 filing · confidence 97%