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  5. Webinar - Multiple Function Device Products: Policy and Considerations - 09/10/2020 - 09/10/2020
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Multiple Function Device Products: Policy and Considerations
September 10, 2020

Date:
September 10, 2020
Time:
11:00 AM - 12:30 PM ET

Webinar Materials

Summary:

On September 10, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and other stakeholders regarding the Multiple Function Device Products: Policy and Considerations final guidance. FDA will discuss the guidance and respond to questions.

Background:

On July 29, 2020, the FDA issued final guidance: Multiple Function Device Products: Policy and Considerations. This final guidance:

  • Incorporates feedback from public comments to clarify and provide examples that describe the FDA's policy on products with multiple functions.
  • Describes medical software provisions of the 21st Century Cures Act as part of the FDA's long-term Digital Health Innovation Action Plan.
  • Identifies the principles, premarket review practices, and policies for the FDA's regulatory assessment for products with multiple functions that include at least one device function.
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