Federal healthcare regulators agreed to add another 2 years onto the "Pilot Program for Parallel Review of Medical Products," allowing more new medical devices to undergo simultaneous review by both FDA and Medicare officials.
The program, launched in October 2011, has since garnered "significant interest" from industry, federal officials said. FDA regulators have spent the last 2 years taking requests for participation in the program and they plan to leave the application process open until 2015.
Once the program to guide a "representative group of participants" through parallel review, healthcare officials will "evaluate the program for best practices and will announce any future revisions and/or enhancements," according to a notice in the Federal Register.
The program was designed to help streamline the pathway that medical technologies follow to get to the market and to make live-saving devices more quickly available to patients.
The two agencies first began sharing data in July 2010 with the singing of a Memorandum of Understanding. The MOU, FDA medtech chief Dr. Jeffrey Shuren said at the time, "will allow for the 1st time routine and timely sharing of information and expertise between our 2 agencies to strengthen our ability to achieve our respective missions."
Industry news sources saw greater potential, however, characterizing the agreement as "a 1st 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.
The project was met with some enthusiasm, but some industry representatives have been skeptical of the program’s practical application. 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.
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 was slated for an initial 2 years with the potential for extension, and is primarily available for innovative technologies that can benefit from simultaneous review. Reviewers are accepting only 3 to 5 submissions per year.
