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FDANonrulemakingFDA-2022-D-2628

Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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Consumer Healthcare Products Association filings
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Consumer Healthcare Products Association filed 1 comment on this docket between Aug 21, 2023 and Aug 21, 2023. 3 other organizations filed here. The comment window closed 1121d ago.

What Consumer Healthcare Products Association filed (1)

Aug 21, 2023· Comment from Consumer Healthcare Products Association (CHPA)· FDA-2022-D-2628-0034

CHPA comments on FDA CDRH's draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions."

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Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (FDA) — Consumer Healthcare Products Association | OpenPolis