FDA Issues Draft Guidance for Predetermined Change Control Plans

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FDA Proposes Recommendations for Presenting Predetermined Change Control Plans in Device Submissions

Dennis Tosh

August 21, 2024 at 03:47 PM EST

Device marketing submissions that include predetermined change control plans (PCCPs) should specify the planned device modifications, the methodology used to develop, validate and implement the modifications, and an assessment of the modifications’ impact, according to important new draft guidance released Aug. 21 by the agency. A PCCP is the documentation describing the modi... Read More

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FDA Proposes Recommendations for Presenting Predetermined Change Control Plans in Device Submissions

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