May 26, 2022· Comment from Advanced Medical Technology Association (AdvaMed)· FDA-2021-N-0507-0078
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FDARulemakingFDA-2021-N-0507
Medical Devices; Quality System Regulation Amendments
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Nov 4, 2024
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Advanced Medical Technology Association filings
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Advanced Medical Technology Association filed 1 comment on this docket between May 26, 2022 and May 26, 2022. 1 other organizations filed here. The comment window closed 1526d ago.
What Advanced Medical Technology 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 →- Advanced Medical Technology AssociationTHIS ORG1 filing · confidence 97%
- Consumer Healthcare Products Associationtrade assoc.1 filing · confidence 97%