The Institute of Medicine will kick off the first of two public meetings on the 510(k) pre-market clearance system for medical devices this afternoon, as part of its investigation into the public health effectiveness of the program.
The IOM, which the Food & Drug Administration tapped for a $1.3 million study of the 510(k) program in September 2009, will conduct the meeting from 1:00 to 5:30 p.m. at the Keck Center of the National Academies in Washington, DC.
The meeting agenda includes a presentation on the history of the 510(k) program and an overview of how it operates, which will be given by representatives from the FDA. A public comment session is scheduled to follow.
While the meeting is full, the IOM said it has set up a teleconference line at 1-866-590-3642 with the meeting code *7577615* for people interested in listening in on the meeting.
Last fall, the FDA picked the IOM to audit the 510(k) program. The study will coincide with its own, internal investigation by the Center for Device and Radiological Health.
The IOM study will address two central questions:
- “Does the current 510(k) process optimally protect patients and promote innovation in support of public health?”
- “If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?”
The review is slated to be finished in March 2011.