The Food and Drug Administration (FDA) announced a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee).
The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will take place virtually on November 29, 2023, from 9 a.m. to 5 p.m. Eastern Time.
The committee will discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests. The committee’s discussion and recommendations from this meeting will help inform future Agency regulatory efforts for these novel tests.