The US Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) have launched a pilot parallel
review program for innovative medical devices. Under the program,
reviewers from FDA’s Center for Devices and Radiological Health (CDRH)
and CMS will simultaneously review devices for both FDA approval and
Medicare coverage. FDA and CMS officials anticipate parallel review will
increase efficiency and help facilitate the development of innovative
new products. “The pilot program will help the FDA and CMS streamline
the parallel review process so that it works efficiently for expedient
patient access to safe and effective medical devices,” said CDRH
Director Jeffrey Shuren.
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