The Food & Drug Administration is making changes to the way its advisory panels deliberate over and vote on medical devices under review by the federal watchdog agency.
As of May 1, the FDA is instituting new procedures for the panels, groups of experts assembled to review and discuss data and information on devices undergoing pre-market review.
"The changes were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices & Radiological Health," according to a press release.
The changes range from centralizing the designated federal officers charged with representing the agency at each meeting to altering the manner of deliberation and how the committees vote:
- CDRH centralized the DFOs and hired a staff of six full-time employees to improve “continuity across CDRH.”
- “For meetings focusing on a particular device that is under review in the agency to determine its approvability, panel discussion has not always reflected a panel’s final vote on approvability,” according to the FDA’s website. “Under the new approach, instead of voting on the approvability of pre-market approval applications, including conditions of approval, the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit.” The change is aimed at allowing panel members to address their areas of scientific expertise, rather than regulatory issues with which they might not be familiar.
- Votes will be by ballot, rather than a show of hands. “While the votes will be publicly tallied so that panel members can be identified by their vote, the ballot process allows each panel member to cast their vote without immediate influence by other votes,” according to the website.
- Panelists will be instructed to present their scientific opinions and recommendations without interruption during an hour-long deliberation, “during which the panel may ask questions of both the sponsor and the FDA. We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel.”
Changes to CDRH presentations
- Rather than having the agency’s reviewers present a consensus analysis of supporting data, reviewers will now present data, analysis and the range of scientific opinion. “By taking a broader view of the data that is supplied and the opinions of different reviewers and offices within CDRH we will provide the panel the ability to have a more in-depth discussion on safety and effectiveness and risk versus benefit of the device at issue.”
"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," CDRH director Dr. Jeffrey Shuren said.