The FDA announced several changes in process yesterday that will affect the way that business is conducted in their Medical Device Advisory Committees, effective May 1, 2010. The press release notes that the changes have been prompted by an increased volume of reviews and panel activity.
FDA Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., stated, "These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts." The changes appear to be intended to make sure that final approvability votes more accurately reflect the content of panel discussions with respect to safety, effectiveness, and the balance of risk versus benefit for a given device.
We've compiled a brief summary of the changes here:
1. Rather than voting on approvability of premarket approval (PMA) applications, panels will vote on the safety and effectiveness of the device and its risk versus benefit. Dr. Shuren stated, "By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes. The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them." Panels will also no longer vote on conditions of approvability.
2. Panel votes will now be conducted by ballot, rather than a simultaneous show of hands. This seems to be intended to allow members to vote their conscience without undue influence from their peers votes. Panel votes will still be publicly tallied so that it will be possible to determine later how individual panel members voted.
3. FDA presentations to the panels will no longer include comments on approvability. They will continue to include reviews of data analysis conducted by the agency.
4. The FDA medical device reviewers will present the committees with data and analysis that reflects the range of scientific opinion amongst the reviewers. This is a change from the agency reviewers' historical tendency to prevent a consensus analysis with a unified front. The FDA notes in the press release that this is intended to encourage more in-depth analysis and discussion related to the safety/effectiveness and risk/benefit balance of the device being considered.
5. Regarding the Advisory Committee Staff, the Designated Federal Officers were recently centralized by CDRH and a staff of six full-time employees has been hired. The FDA notes that this is intended to improve continuity across CDRH.
The FDA's press release regarding these changes is available by clicking here.
The FDA's summary of the changes to CDRH's advisory committee process is available here.
The CDRH Advisory Committee Tentative 2010 calendar is available here.
FDA Medical Devices Advisory Commitees
The following is quoted from the FDA website:
"The Center for Devices and Radiological Health has established advisory committees to provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation. Each committee consists of experts with recognized expertise and judgment in a specific field. Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These persons are not regular employees of FDA, but are paid as 'special government employees' for the days they participate as members of a panel. This is time they take from their daily occupations to provide their professional skills to FDA. The committees are advisory--they provide their expertise and recommendations--but final decisions are made by FDA."
"The Center has four advisory committees, including a Medical Devices Advisory Committee which consists of 18 panels that cover the medical specialty areas."
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