The FDA’s newly formed Patient Engagement Advisory Committee will meet for the first time tomorrow and Thursday to discuss patient input on medical device clinical trial.
The agency said the meeting will help it gain input on understanding patient challenges and how to use patient input in medical device trials as it looks to make patient inclusion a more important part of medical device regulation.
The federal watchdog said the meeting will “provide the opportunity to bring patients, patient organization, FDA, industry, and other medical and scientific experts together for a broader discussion on this important patient-related issue,” according to its release.
The meeting will also allow the FDA to gain recommendations from the Patient Engagement Advisory Committee on “top areas for the FDA to consider for action,” it said.
The FDA said that the meeting will be open to the public.
Earlier this month, the FDA released seven new, or updated, guidance documents relating to its user fee programs and performance goals outlined in the fourth version of the Medical Device User Fee Amendments.