Webinar - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance - March 22, 2022

The U.S. Food and Drug Administration (FDA) will host a webinar on March 22, 2022 from 1:00 PM - 2:30 PM ET for stakeholders to share information and answer questions about the final guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.  This webinar will: Describe how voluntary inclusion of some patient engagement activities may enhance the design and conduct of clinical studies Describe which patient engagement activities are generally not considered by the FDA to constitute an activity subject to the FDA's regulations regarding Institutional Review Boards (IRBs) Clarify how sponsors can receive feedback from the FDA on plans to voluntarily include patient advisor input on their clinical study, through the Q-submission process Read More   If you have any questions about this guidance document, please contact FDA's Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100. Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA