FDA and CMS to Begin Pilot Program for Parallel Review of Medical Products

October 11, 2011—The US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced that the agencies are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for concurrent review of certain FDA premarket review submissions and CMS national coverage determinations. The pilot program is voluntary, and it is only available for qualifying new medical device technologies. It will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination, advised the agencies.

The agencies noted that innovators have generally focused solely on obtaining FDA approval, only to later realize that Medicare payment may not automatically be forthcoming. Parallel review is intended to reduce the time between FDA marketing approval and CMS national coverage determinations in order to improve the quality of patient health care by facilitating earlier access to innovative medical products for Medicare beneficiaries.

Complete details of the program can be found in the agencies' notification published in the Federal Register (2011;76:62808-62810).

“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,” stated Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH).

CMS Chief Medical Officer Patrick Conway, MD, added, “The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes.”

After announcing the intention to initiate a pilot program in the Federal Register in September 2010, the agencies are now providing notice of the procedures for voluntary participation in the pilot program, as well as the guiding principles the agencies intend to follow. Device sponsors interested in requesting voluntary parallel review should contact Markham C. Luke at the FDA's CDRH by phone at (301) 796-5550 or by e-mail at markham.luke@fda.hhs.gov. General questions about parallel review should be addressed to Peter Beckerman at the FDA's Office of Policy at (301) 796-4830 or peter.beckerman@fda.hhs.gov; Tamara Syrek Jensen at CMS can be reached at (410) 786-3529 or tamara.syrekjensen@cms.hhs.gov.

In the Federal Register, the agencies have outlined guiding principles underlying the pilot program; appropriate candidates for the pilot program; procedures FDA and CMS intend to follow in conducting parallel product reviews; and general roles and responsibilities of the sponsor/requester, the FDA, and CMS.

The agencies also intend to seek input and feedback from candidate sponsor/requesters who participate in the pilot, and they intend to accept requests for participation in the pilot program for parallel review for 2 years. The pilot may be terminated before the close of the 2-year period, or may extend the pilot program beyond 2 years, and any decisions will be announced in the Federal Register.

Current information describing the FDA-CMS Parallel Review Pilot Program for Medical Devices can be found at the FDA Web site.

In related news, on October 3, the CDRH released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products. The report, “Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health,” surveys the FDA's efforts to foster science that enables and supports innovation and sound medical product development. It is intended to give clinicians, researchers, patient groups, and the medical device industry an idea of the scope of the scientific activities at CDRH and how they support device innovation and protect public health.

“The regulatory science plan provides an informative and transparent look at the work we conduct in collaboration with industry and academia to facilitate the development, assessment, review, and manufacturing of medical devices that will benefit patients more quickly and at a lower cost to industry,” commented William Maisel, MD, Deputy Director and Chief Scientist at CDRH.

The FDA stated that investments in regulatory science can help reduce the time and resources needed to develop, assess, and test new products. This can lead to quicker, more efficient device approvals, potentially decrease the size and duration of premarket clinical trials, and speed the rate at which breakthrough technologies reach the market.

Dr. Maisel added, “This report provides evidence of the FDA's commitment to evolving the methodology and science it uses to review products to keep pace with the rapid progression of the science used in product development.”

In August, the FDA released its “Strategic Plan for Regulatory Science,” which touches on several priorities identified in greater detail in CDRH's regulatory science report.