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  5. Webinar - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance - 03/22/2022
  1. Workshops & Conferences (Medical Devices)

Webcast

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

Date:
March 22, 2022
Time:
1:00 PM - 2:30 PM ET

Summary: 

The U.S. Food and Drug Administration (FDA) will host a webinar 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

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Background: 

The FDA believes including input from patient advisors early in clinical study design may address common challenges, and could result in improved recruitment, retention, and adherence, faster study completion, fewer protocol deviations, as well as streamlined collection of data which is more focused on outcomes that matter to patients.

The FDA developed this guidance based on recommendations during the Patient Engagement Advisory Committee Meeting in October 2017 and feedback on a discussion document issued in November 2018 and draft guidance issued September 2019.  This final guidance is intended to provide clarity to device developers, sponsors, and industry about how to use patient engagement in clinical studies to improve design and conduct.

Providing patients and their family caregivers the opportunity to provide their insights about a disease or medical condition, including living with that disease or condition as well as the impact of medical devices in the diagnosis, treatment, and management of their disease or condition, can inform and improve the clinical study process. As a result, these patient engagement activities can help medical device developers obtain experience, perspectives, and other relevant information to improve the design and conduct of medical device clinical studies. 

Webinar Details:

Registration is not necessary.

Date: March 22, 2022
Time: 1:00 PM - 2:30 PM ET

To ensure you are connected, please dial-in 15 minutes before the start of the webinar.

Please click the link below to join the webinar: 

Please note: Participants who join 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 by phone only.

After the webinar, a transcript, recording, and slides will be posted below.


Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Patient organizations, Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations and other non-profit organizations.

If you have any questions about this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration Center for Devices and Radiological Health

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