• Summary
• Background
• Webinar Details
• Webinar Materials

Summary

On July 20, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss the final guidance: Content of Premarket Submissions for Device Software Functions.

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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Background

The purpose of this guidance is to describe the FDA's thinking on the recommended documentation sponsors should include in premarket submissions for the FDA's evaluation of the safety and effectiveness of device software functions. This guidance replaces the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005 and describes information that would be typically generated and documented during software development, verification, and validation. This thinking recognizes changes to the FD&C Act made by the 21st Century Cures Act (Cures Act), which amended section 520 of the FD&C Act and excludes certain software functions from the device definition. It also considers the rapidly evolving nature of digital health and recent FDA-recognized consensus standards related to software.

Webinar Details

Registration is not necessary.

Date: July 20, 2023

Time: 1:00 PM - 2:00 PM ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the webinar: https://fda.zoomgov.com/j/1618744961?pwd=MmdVdEd1YnVscHF2K01TWlp6QU45QT09 

Passcode: HHq6&G

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

• U.S. Callers Dial: 833-568-8864 (Toll Free)
  • For higher quality, dial a number based on your current location:
    • +1 669 254 5252 US (San Jose)
    • +1 646 964 1167 US (US Spanish Line)
    • +1 646 828 7666 US (New York)
    • +1 551 285 1373 US
    • +1 669 216 1590 US (San Jose)
    • +1 415 449 4000 US (US Spanish Line)
• International Caller Dial: Please check the international numbers available
• Webinar ID: 161 874 4961
• Passcode: 406547

Webinar Materials

The presentation, printable slides, and transcript will be available at CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health."

If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at digitalhealth@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.