FDA Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
- Date: March 31, 2020
- Time:8:30 AM – 4:30 PM ET
- Organized By: Center for Devices and Radiological Health
The Food and Drug Administration (FDA), along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public workshop entitled “Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond”. The purpose of the public workshop is 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 workshop will provide 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 will be discussed include the value of including PPI in different settings, case studies highlighting the use of PPI, and methodologies for collecting PPI.
The public workshop will be webcasted live and the link will be posted on the website for viewing after the workshop.
Please visit the ISPOR website to register for the pre-event webinar and workshop: https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-fda-summit-2020
- 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)
- MDIC Patient Centered Benefit-Risk Framework