Medical Innovation Exchange

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions



The FDA has released a final guidance on premarket submissions for device software functions. “Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. This includes risk management files, software requirement specifications, software design specifications and unresolved software anomalies. The guidance includes two appendices with documentation level and system and software architecture diagram examples.

The final guidance replaces FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005, and updates the agency’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.

Industry and other interested stakeholders can join the FDA on July 20, 2023, from 1:00pm-2:00pm ET on a webinar to discuss the final guidance. During this webinar, the FDA will:

  • Discuss the risk-based approach to determining the recommended documentation level for a premarket submission
  • Discuss the recommendations for information to be included in premarket submissions for Basic and Enhanced Documentation Levels.
  • Answer questions about the final guidance.

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