October 17, 2011 — The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have established a pilot program for concurrent review of medical devices. Under the process, certain FDA premarket review submissions and CMS national coverage determinations will be simultaneously reviewed.
Reducing the interval between FDA marketing approval and medical reimbursement coverage will facilitate development and shorten the time it takes to bring products to patients.
During its pilot phase, the agencies said they will offer to perform parallel review for up to five innovative devices per year. Appropriate candidates are medical devices that meet one of the following criteria:
- New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation.
- New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review.
- 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).
The pilot program is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is only available for medical device technologies that meet the above criteria.