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Reminder: Join Us Tomorrow for a Webinar on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies – Final Guidance
The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.
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Date: Tuesday, March 22, 2022
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Time: 1:00 p.m. to 2:00 p.m. ET
Registration: No registration required. View webinar details for call-in information.
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During this webinar, the FDA 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
- Answer your questions about the Patient Engagement in the Design and Conduct of Medical Device Clinical Studies final guidance.
Questions?
If you have questions about Patient Engagement in the Design and Conduct of Medical Device Clinical Studies final guidance, contact the Division of Industry and Consumer Education.
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