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FDA Extends Parallel Review Program ‘Indefinitely’

 
• By Elizabeth Orr

The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.

A program that allows medical device sponsors to pursue FDA approval and Medicare coverage simultaneously is being “fully implemented and extended indefinitely” after a five-year pilot period, FDA announced in an Oct. 24 Federal Register notice. The notice states that CMS and FDA are actively looking for innovative products that might be eligible for the parallel review program, which is designed to reduce the time between when FDA grants PMA approval or a de novo classification and when Medicare issues a national coverage determination. This, the agencies hope, will improve outcomes by allowing patients to access new technologies more quickly.

FDA and CMS announced plans for the parallel review pilot program on Sept. 17, 2010. The agencies began recruiting companies for a pilot program on Oct. 11, 2011, and announced...

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