CMS, FDA Pair Up for Parallel Reviews

CMS and the FDA are hoping that by pairing up, they can encourage the development of innovative new products and shorten the amount of time it takes to bring those products to consumers.

The two agencies will be performing parallel reviews (FDA premarket review submissions for medical devices and CMS national coverage determinations). During the pilot phase, they'll review up to five innovative devices per year. To be eligible, medical devices need to meet one of the following criteria:

1. New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation.
2. New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review.
3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision (NCD).

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