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FDA, CMS Seek to Speed Device Decisions

NEW YORK (GenomeWeb News) – The US Food and Drug Administration and the Centers for Medicare and Medicaid Services are weighing the use of a parallel review process for medical devices that would speed up the process of making coverage decisions, and they have started a pilot program to try out the idea.

In a notice published today FDA said that the Parallel Review plan is intended to reduce the time between FDA marketing approval and CMS national coverage determinations, which could improve care by bringing new medical products to more patients sooner, would increase efficiency in the government, and facilitate development of new devices.

To start the program, the agencies are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program to test the concurrent review of FDA premarket review and CMS coverage determinations.

The agencies took comments from the public last year that suggested, among other things, that a parallel review program should be voluntary, should include an opt-out from national coverage determinations, should have clear standards for confidentiality and data sharing between the agencies, and should have clear guidelines on the procedure and timeline for the review process.

FDA and CMS said those comments informed the development of this medical device pilot program and the agencies intend to seek input and feedback from the candidate sponsors and requesters who are involved in the pilot.

For more on the pilot program see GenomeWeb Daily News sister publication Pharmacogenomics Reporter.

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