Workshop | Virtual
Event Title
Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle
June 26 - 27, 2024
- Date:
- June 26 - 27, 2024
- Day1:
- - ET
- Day2:
- - ET
- Summary
- Background
- Date and Time
- Webcast
- Preliminary Agenda
- Registration
- Comments
- Contact Us
- References
Summary
The Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the Digital Medicine Society (DiMe) titled "Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle." The purpose of this co-sponsored public workshop is to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle (TPLC). Patients, industry sponsors, regulators, and researchers will share their perspectives on how using PGHD can help advance remote clinical trial data collection and support clinical outcome assessments. The co-sponsored public workshop participants are slated to discuss how using PGHD in medical device development can promote improvements in patient science, patient engagement, and health equity.
Background
The FDA's Center for Devices and Radiological Health (CDRH) is committed to amplifying the patient voice in the service of equitable access to safe, effective, and high-quality medical devices. PGHD has the potential to help the CDRH meet this commitment in line with our strategic priority of advancing health equity. CDRH has been formally exploring and advancing the collection of PGHD since 2016.1 This co-sponsored public workshop builds upon the past work – including the Patient Engagement Advisory Committee meeting in 20182 and a public meeting in 20213 – by discussing case examples of how PGHD has been incorporated at the different phases of the TPLC.
The aims of this co-sponsored public workshop are to explore how patient-generated health data can achieve the following:
- Advance remote clinical trial data collection and support clinical outcome assessments.
- Capture patient perspectives and reduce patient burden to inform clinical study design and conduct, with a goal of reducing barriers to patient participation and facilitating recruitment and retention.
- Improve patient science tools for medical devices and advance health equity through targeted incorporation of diverse patient perspectives and integration of data from diverse patients.
Date and Time
This meeting will be held on June 26-27, 2024, from 11:00 am - 3:00 pm (ET) by webcast only.
Webcast
The co-sponsored public workshop will be webcast. Register to receive the link to the webcast in a confirmation email. After the live webcast, a link for the recorded co-sponsored public workshop will be posted to the FDA webpage.
Preliminary Agenda
The following co-sponsored public workshop agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
June 26, 2024
| Time | Subject | Name of Speaker |
|---|---|---|
| 11:00 am | Welcome Remarks | TBD |
| 11:05 am | Sessions | TBD |
| 2:55 pm | Concluding Remarks | TBD |
| 3:00 pm | Adjourn Day 1 |
June 27, 2024
| Time | Subject | Name of Speaker |
|---|---|---|
| 11:00 am | Welcome Remarks | TBD |
| 11:05 am | Sessions | TBD |
| 2:55 p.m. | Concluding Remarks | TBD |
| 3:00 pm | Adjourn Day 2 |
Registration
If you wish to attend this co-sponsored public workshop and receive the link to the live webcast, please register by 4:00 p.m on June 25, 2024. For registration, please visit: https://us02web.zoom.us/webinar/register/WN_piEgChG3RIWfXZ3vG1VOFA#/registration
There is no fee to register for the Workshop.
Registrants will receive confirmation when requests for registration have been processed. If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.
Comments
Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2024-N-2441 by July 29, 2024.
Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible http://www.regulations.gov/.
Contact Us
For questions regarding the co-sponsored public workshop content, please contact:
Robert Wright
Office of Strategic Partnership and Technology Innovation
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
robert.wright@fda.hhs.gov
References
- Webber, C. M., Riberdy Hammer, A., Saha, A., Marinac-Dabic, D., Caños, D. A., & Tarver, M. E. (2023). Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices. Therapeutic Innovation & Regulatory Science, 1-5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10400470/
- Advisory Committee Meeting November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement [Internet]. Silver Spring: U.S. Food & Drug Administration; 2018 [updated 2018 Dec 11; cited 2022 Aug 8]. Available from https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-15-2018-patient-engagement-advisory-committee-meeting-announcement-11152018
- U.S. Food & Drug Administration. Patient-generated health data throughout the total product life cycle of medical devices, virtual. 4 May 2021. https://public4.pagefreezer.com/browse/FDA/28-12-2023T13:10/https:/www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-patient-generated-health-data-throughout-total-product-life-cycle-medical