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FDA, CMS Launch Pilot Program for Voluntary Parallel Review of Innovative Devices
Date:10/7/2011

new medical device technologies.  

The Federal Register notice also outlines the agencies' commitment to ensuring that submitted data is confidential and highlights when sponsors can opt-out of the parallel review program.  

The pilot program, which will last for up to two years with the possibility for extension, will focus on innovative technologies that can benefit from the efficiencies of parallel review. The pilot program will accept no more than three to five submissions per year.

In September 2010, the FDA and CMS announced their intention to implement a parallel review process, and received 37 public comments, which can be found in the public docket.

For more information and to read the Federal Register notice:

FDA-CMS Premarket Review

http://www.fda.gov/parallel-review.

Medicare Coverage Center

http://www.cms.gov/center/coverage.asp

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For Immediate Release: Oct. 7, 2011
Media Inquiries: FDA – Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov;
CMS – Media Relations Group, 202-690-6145, OEABox@cms.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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