FDA Advisor Tapped for Science Council

The U.S. Food and Drug Administration (FDA) certainly is quick to follow its own advice.

Within days of releasing a comprehensive report last month that recommended ways it could improve the medical device approval process, the agency began following through on one of the suggestions.

On Aug. 4, the FDA’s Center for Devices and Radiological Health (CDRH) released two major reports recommending actions the Center could take to change the way it oversees medical devices. The first report provided preliminary recommendations to strengthen the 510(k) premarket review process. The second report discussed a task force finding regarding CDRH’s use of science in decision making and managing the device approval process as science evolves. A key element of this second report is the creation of a new Center Science Council (CSC) to guide CDRH in science-based decision making.

The mission and makeup of the CSC is still somewhat vague, though an FDA report in early August said it “should meet regularly and be available, as needed, to discuss and vet potential changes in the Center’s regulatory expectations on which staff at lower organizational levels wish to seek additional advice from a wider range of experts, or whose impact could be cross-cutting enough to warrant broad or Center-level attention. Another role for the Science Council relates to increasing the consistency of 510(k) decision-making.”

Sometime during that first week in August, CDRH Director Jeffrey Shuren hired William Maisel, M.D., to lead the CSC. The exact date of Maisel’s appointment is unclear because the FDA has not issued a formal news release about the move.

Maisel is an electrophysiologist at Harvard/Beth Israel Deaconess Medical Center in Boston, Mass. A prominent expert on medical device safety who often has been critical of the industry, Maisel is the founder and director of the Medical Device Safety Institute, a Boston-based organization dedicated to improving the safety and reliability of medical devices.

Maisel has been a consultant to CDRH since 2003 and previously chaired the FDA’s Post Market and Heart Device advisory panels. He received his medical degree from Cornell University, his master’s degree in Public Health from the Harvard School of Public Health, and completed his internal medicine and cardiovascular training at Brigham and Women’s Hospital in Boston.