FDA and CMS Launch Voluntary Parallel Review for Innovative Products

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On October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced the official launch of the parallel review program. An effort to increase patient access to a variety of medical devices and drugs, the program is designed to facilitate the development of innovative medical products and reduce the time between FDA approval and CMS national coverage determinations.

In September 2010, FDA and CMS announced their intentions to implement a pilot parallel review program for innovative medical devices, drugs, and biological products. Please see our previous report for more information regarding the announcement of the program. In response to the initial Federal Register Notice, the Agencies received 36 public comments regarding what products would be appropriate for parallel review, what procedures should be developed, and how a parallel review process should be implemented.

The Federal Register Notice announcing the implementation of the program details the procedures for the programs voluntary participation and guidelines for the Agencies to follow during the review of a product. The program will not change the existing separate review standards for FDA product approval and CMS coverage determinations. However, parallel review may ultimately benefit patients by expediting the time involved with the review process, as the separate determinations will run concurrently. In order to qualify for the program, product candidates must 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; or
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).

The FDA and CMS are currently accepting submissions for products seeking parallel review. The Agencies intend to perform parallel reviews for up to five products per year for the next two years, with the possibility for extension.

Fuerst Ittleman, PL will continue to monitor the progress of the FDA and CMS parallel review program. For more information on how FDA and CMS review medical products and how the parallel review process may be beneficial to your product, please contact us at contact@fidjlaw.com.