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Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech
Artificial IntelligenceMedical DevicesSaMDOctober 15, 2024

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

By Shawn M. Schmitt Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and...

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