Webinar: Draft Guidance for Premarket Submissions for Device Software Functions

U.S. Food and Drug Administration sent this bulletin at 12/15/2021 07:29 AM EST

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FDA - Center for Devices and Radiological Health

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Reminder: Join Us Tomorrow for a Webinar on Draft Guidance Content of Premarket Submissions for Device Software Functions

The U.S. Food and Drug Administration (FDA) will host a webinar to provide an overview of and answer questions about the proposed recommendations in the Draft Guidance: Content of Premarket Submissions for Device Software Functions.

  • Date: Thursday, December 16, 2021
  • Time: 1:00 p.m. - 2:00 p.m. ET
  • Registration: No registration required. View webinar details for call-in information.

View Details

During this webinar, the FDA will:

  • Discuss how this draft guidance, if finalized, would provide recommendations intended to streamline the organization and content of the software documentation and provide helpful prompts and tips to identify the minimum amount of information that, based on FDA’s experience, would generally be needed to support a premarket submission for a device that uses software.
  • Highlight how this draft guidance is intended to complement previously issued guidance that also includes software-related recommendations.
  • Answer your questions about the draft guidance.

Questions?

If you have questions about device software functions, contact the Division of Industry and Consumer Education.