FY2022 SW Related Guidance

“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance.

This year’s FY2022 Software Related Guidance list is ambitious, and I applaud the FDA CDRH team for taking on this huge challenge. After they start publishing, we the industry will be very busy reading, understanding, and implementing the new and updated “current thinking” from the agency.”

On October 26, 2021, the FDA posted CDRH Proposed Guidances for Fiscal Year 2022 (FY2022).

FY2022 Final Guidance List:

  • Clinical Decision Support Software

FY2022 Draft Guidance List:

  • Computer Software Assurance for Production and Quality System Software
  • Cybersecurity in Medical Devices: Quality Considerations and Content of Premarket Submission
  • Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)

FY2022 Draft Time Permitting List:

  • Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations

FY2022 Retrospective Review List:

  • General Principles of Software Validation: Guidance for Industry and FDA Staff

“By the way, the GPSV is one of my favorites. In the late 1990’s I worked on it for about 4 years during the same time frame that the agency was dealing with the Year 2K software crisis.”

Looking back to the FY2021 list:

  • Clinical Decision Support Software
  • Computer Software Assurance for Production and Quality System Software
  • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Content of Premarket Submissions for Software Contained in Medical Devices
  • Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations
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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