CDRH Proposed Guidance Updates

FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these very important topics.

The following software related guidance items are on CDRH’s A-list:

  • FDA intends to publish Final Guidance for Clinical Decision Support Software
  • FDA intends to publish Draft Guidance for Computer Software Assurance for Manufacturing and Quality System Software
  • FDA intends to publish Draft Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • FDA intends to publish Draft Guidance for Content of Premarket Submissions for Software Contained in Medical Devices

The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2021.

View the proposed list from FDA here:

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

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