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FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions

June 15, 2023

On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions.

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

Read the Guidance Here »

Facts about the final guidance

  •  This final guidance fulfills an FDA commitment in MDUFA V and is intended to provide clarity, simplicity, and harmonization with current best practices and recognized voluntary consensus standards.
  • The final guidance takes a simplified risk-based approach to help determine the device’s Documentation Level, which is either Basic or Enhanced. The Documentation Level helps to identify the minimum amount of information that would support a premarket submission that includes device software functions.
  • CDRH staff does not generally intend to request the newly recommended information outlined in this guidance during the review of the submission for submissions received through August 13, 2023. CDRH does, however, intend to review any such information if submitted.

Upcoming Webinar on this Guidance

On July 20, 2023, the FDA will host a webinar for medical device manufacturers and other stakeholders interested in learning more about the final guidance and the recommendations for documentation sponsors should include in premarket submissions.