3 Topic Commentaries

FDA change plans in radiology AI

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  Scott Gottlieb, MD

  Regulatory policy; medicine

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  U.S. Food and Drug Administration (FDA)

  The predetermined change control plan would provide detailed information to the agency about the types of anticipated modifications.

  Source
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  Nicholas Petrick, PhD

  Medical imaging; AI/ML evaluation; regulatory science

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  U.S. Food and Drug Administration (FDA)

  In general, yes, this final guidance is applicable to AI-enabled device software functions that a manufacturer intends to modify over time.

  Source
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  Amir Khan, PhD

  Radiology AI; imaging software; device regulation

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  U.S. Food and Drug Administration (FDA)

  FDA strongly encourages manufacturers to consider discussing a proposed PCCP for a generative AI-enabled device with FDA through a Pre-Submission.

  Source