FDA, CMS extend parallel review program indefinitely

The FDA and Centers for Medicare & Medicaid Services said today that the Parallel Review of Medical Devices pilot program will be fully implemented and extended indefinitely.

The program from the FDA is a collaborative effort “intended to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and Medicare coverage decisions,” according to a release from the FDA.

The program is set to be fully implemented today, at the time that the FDA published its release, the agency said.

The program aims to allow more new medical devices to undergo simultaneous review by both the FDA and Medicare officials, according to the agency.

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.”

The FDA and CMS extended a pilot program of the service by 2 years in 2011.

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