FDA Changes Medical Device Review Process

May 6, 2010

On May 1 the U.S. Food and Drug Administration changed the way expert panels analyze whether a medical device should be approved for the general market, hoping a new approach will streamline the premarket process and improve discussions. The changes were spurred by the higher frequency of panel meetings, reflecting both the increasing number of premarket applications and an unfocused flow of information on numerous topics during those meetings. In 2008, there were 10 panel meetings covering 14 major topics, compared with 17 meetings covering 20 topics in 2009; the figures are expected to rise further in 2010.

Panel members conducting premarket public hearings will now be asked to vote on the safety and effectiveness of a device and its risk-benefit ratio, rather than the approvability of premarket applications and conditions of approval. The changes will allow panelists to analyze a product according to substantive scientific data instead of administrative considerations, an approach that may help squelch inconsistencies between the substance of panels’ discussions and their final votes on approvability. “By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement. “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.”

In addition, the FDA has implemented a ballot voting procedure rather than a simultaneous show of hands, a move that should make panelists more willing to be honest, according to the statement. “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 his or her vote without immediate influence by other votes,” the FDA stated.

Finally, while CDRH panels previously presented a unified consensus after analysis, new procedures will allow them to offer a range of scientific opinion as it differs among the group, the FDA said.

For more information on these changes and their implications for medical device companies, please contact the author.