Public Meeting - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
September 29, 2020
- September 29, 2020
- Organized By:
The Food and Drug Administration (FDA), along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public meeting entitled "Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond" that will be held by webcast only. The purpose of the public meeting was to discuss and explore potential applications, challenges, and opportunities of using Patient Preference Information.
Patient preference information (PPI) is increasingly being used in regulatory decision making for medical devices. This meeting provided a forum to engage key stakeholders, including patients, researchers, regulators, payers, and the life sciences industry, to discuss and explore potential applications, challenges, and opportunities of using PPI across the healthcare ecosystem. Topics that were discussed include the value of including PPI in different settings, case studies highlighting the use of PPI, and methodologies for collecting PPI. Additional topics are outlined in the Agenda below. A pre-event webinar "PPI Primer" is available to all online.
DATE AND TIME
This meeting was held on September 29, 2020, from 10:30 a.m. to 4:45 p.m. (ET) by webcast only.
WEBCAST MEETING LINK
The archived webcast link will be available for one year from the date of the event.
Presentations are now hyperlinked within the agenda for viewing.
|10:30 a.m. - 10:45 a.m.||Logistics and Welcome||Nancy Berg
Suzanne Schrandt, JD
|10:45 a.m. - 11:30 a.m.||Introduction and background of patient-preference information (PPI)||Brett Hauber, PhD
Anindita Saha, BSE
Christina Webber, PhD
|11:30 a.m. - 1:00 p.m.||Case Studies for Use of PPI in Medical Device Decision-Making Processes||Dan Harfe, MSE, MBA
Barry Liden, JD
Christine Poulos, PhD
Todd Snell, MBA
Kimberly Brown Smith, MD, PhD
Michelle Tarver, MD, PhD
|1:00 p.m. - 1:30 p.m.||Lunch Break|
|1:30 p.m. - 3:00 p.m.||Methodologic Issues for PPI Studies||Ryan Fischer
David Gebben, PhD
Juan Marcos González, PhD
Bennett Levitan, MD, PhD
Shelby Reed, RPh, PhD
|3:00 p.m. - 3:15 p.m.||Break|
|3:15 p.m. - 4:30 p.m.||Implementation / Process of Obtaining and Using PPI - the 'Beyond'||Dean Bruhn-Ding
Louis Jacques, MD
Ravi Jayadevappa, PhD
Lucinda Orsini, DPM, MPH
|4:30 p.m. - 4:45 p.m.||Closing Remarks||Michelle Tarver, MD, PhD|
For questions regarding meeting content please contact:
Michelle Tarver, MD, PhD
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
- Patient Preference Information (PPI) in Medical Device Decision-Making
- CDRH Patient Engagement
- Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (FDA Guidance)
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (FDA Guidance)
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (FDA Guidance)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions (FDA Guidance)
- Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (FDA Guidance)
- MDIC Patient Centered Benefit-Risk Framework