This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is meant to include guidance and policies, clinical trial design and patient preference related to host of issues. FDA also stated that the committee would be put to work identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequence that could result from FDA policy.
Some specific things FDA says that it is considering asking from this committee include identifying the points, and presumably the process, for patients to provide input during the life cycle of a medical product – from pre-approval to post-approval, and also determining that the priorities and focus should be for such input.
There will be nine voting members of the committee who have backgrounds or expertise in clinical research, primary care and in general of health care needs and trends. The committee will operate like other advisory committees, with staggered terms and may have non-voting members such as an Industry Representative.
This is the second step FDA has made that institutes some changes in the medical device world Earlier in the month, the agency announced the release of information through OpenFDA. In a September 3 blog posting on FDA Voice the agency stated that they were making already public information on medical device adverse events and recalls more readily available through FDA’s Application Programming Interface to expand access to the data.
The establishment of such a committee will likely be viewed as a good thing by patient advocates. FDA also published a notice for individuals and organizations potentially interested in serving on the committee.