Medical device companies can opt to shave some time off their device clearance and Medicare reimbursement reviews by opting to have both applications considered simultaneously.
The FDA and the Centers for Medicare & Medicaid Services launched a "parallel review" pilot program for voluntary simultaneous review and med-tech companies wanting to give it a try can sign up beginning today.
"The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices," CDRH director Dr. Jeffrey Shuren said in a press release.
Both agencies use clinical data to make decisions and running simultaneous review may help cut down the overall time it takes for a product to reach the market.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," CMS chief medical officer Dr. Patrick Conway said in the release. "Our goal is to reduce regulatory burden and improve patient outcomes."
The two agencies first began sharing data in July 2010 with the singing of a Memorandum of Understanding.
The MOU, Shuren said at the time, "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions."
Industry news sources saw greater potential, however, characterizing the agreement as "a first step toward parallel reviews for marketing approval and Medicare coverage."
That prediction came to pass just months later when the FDA and CMS announced plans to team up on medical devices in September 2010.
While the program was met with some enthusiasm, some industry representatives were skeptical that the program would work on a practical level. Some worried that increased collaboration could have other side effects, such as reimbursement coverage decisions influencing whether or not a device makes it through the approval process.
"There’s an awful lot going on at FDA and CMS and I don’t think it would be in anyone’s best interest to tackle too much integration between the two entities at a time when they’re both going through substantial reform in their own right," president Stephen Ubl said at the time.
The parallel review program does not alter the different review standards for either agency, and is voluntary for companies eager to give it a try.
The pilot will last for up to two years with the potential for extension, and is primarily available for innovative technologies that can benefit from simultaneous review. It will only take 3 to 5 submissions per year.
