TOP OF THE NEWS
FDA Names Maisel to Lead
New Internal Review Board
The U.S. Food and Drug Administration
(FDA) certainly is quick to follow its own ad-
vice. Within days of releasing a comprehen-
sive report last month that recommended
ways it could improve the medical device
approval process, the agency began follow-
ing through on one of the suggestions.
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Medical Device Regulatory Training
(attend one or more courses)
FDA CDRH Recall Branch Chief, Rita Hoffman, added as an instructor.
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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
The mission and makeup of the CSC
remains 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 Cen-
ter-level attention. Another role for the
Science Council relates to increasing the
consistency of 510(k) decision making.”
CDRH Director Jeffrey Shuren hired
William Maisel, M.D., to lead the CSC.
Maisel is no stranger to the inner workings
of the agency. He has served on a number of
FDA advisory committees for new medical
device approval. He has been a consultant to
CDRH since 2003 and previously chaired the
FDA’s Postmarket and Heart Device
Maisel is an electrophysiologist at Har-vard/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. 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.
STJ Buys Stake in Novel Cardio
Firm, Possible Future Purchase
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