Title: What Does It Mean by a Device’s Benefits Outweigh the Risks? Benefit-risk Assessment of Medical Devices for Regulatory Decision Making
Presenter: Martin Ho, Associate Director for Quantitative Innovations, CDRH, FDA
Date and Time: Tuesday, January 15, 2019, 1:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Section on Medical Devices and Diagnostics
Registration Deadline: Friday, January 11, at 12:00 p.m. Eastern time
Statisticians’ instrumental roles in ensuring appropriate design, conduct, analysis, and interpretation of clinical studies have been widely recognized in scientific community. Yet clinical evidence is one of multiple important factors to inform regulatory decision making at CDRH. To appreciate the regulatory values of clinical and non-clinical evidence in submissions, statisticians may benefit with a better understanding of how CDRH evaluates thousands of distinct medical device types. To promote policy transparency and consistency, CDRH first published a guidance document on factors to be considered for benefit-risk determinations for PMA, de novo, and HDE decisions. To further explain individual factors listed in the 2013 “parent” guidance, CDRH has released subsequent “children” guidance documents. The suite of benefit-risk guidance documents has recently been completed by the release of a draft guidance in September 2018 on acceptable level of uncertainty.
In this webinar, I will first describe CDRH’s benefit-risk framework and its relationship to CDER’s own framework. Next, I will discuss individual factors of the framework in details, including patient preference information, patient-reported outcomes, and uncertainty. Next, I will take a step back and explain the relationship between statistical significance and clinical meaningfulness. Finally, I will provide some interesting examples for illustrations.
Member of the Section for Medical Devices and Diagnostics (MDD): $0
ASA Member: $65
Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
Registered persons will be sent an email the afternoon Friday, January 11, with the access information to join the webinar and the link to download and print a copy of the presentation slides.