FDA Law Blog

MAY 8, 2023

Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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Drafting Manufacturing Data Management Technology 98

FDA Law Blog

OCTOBER 10, 2022

The statute achieves this through disclosure of information by the software manufacturer about the “basis for” the recommendations made by the software. FDA’s novel reading of Criterion 3 may dramatically affect the regulatory status of CDS software that includes risk probabilities or risk scores as outputs.

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Drafting Statute Data Management Manufacturing 52

FDA Law Blog

JUNE 12, 2022

established by statute and case law. The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . This fraudulent inducement theory is well?established

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Manufacturing Contract Data Management Statute 52