Global Regulatory Pulse

Clinical Trials for Innovative Devices: Concurrent Review by FDA/CMS Leads to Time and Cost Efficiencies

In FDA, Regulatory by Kristy Katzenmeyer-Pleuss

Since 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have jointly run a pilot program to perform parallel reviews of clinical data submitted to the agencies for pre-market application approval and national coverage decision, respectively. This program – referred to as the Parallel Review Program – was initiated in an attempt to reduce the time required for innovative medical devices to reach the market.

Both the FDA and CMS announced on October 24, 2016, that the Parallel Review Program will be “fully implemented and extended indefinitely.” What this means for medical device manufacturers is the opportunity to design and conduct one pivotal study that will be accepted by both the FDA and CMS, providing not only time efficiencies, but also significant cost savings.

The Parallel Review Program consists of two stages. In the first stage, the FDA and CMS provide feedback on a proposed clinical trial through the FDA’s established Pre-Submission Program. In the second stage, the FDA and CMS review the clinical trial results submitted in the pre-market approval (PMA) or De Novo submission.

According to FDA’s website, requests to participate in the Parallel Review Program should include the following information:

  • Name and contact information of the sponsor/requester
  • Device name and proposed indications for use/intended use
  • Device description, including stage of development of the technology
  • Submission number (if applicable)
  • Statement that the manufacturer intends to meet jointly with the FDA and CMS utilizing the FDA’s Pre-Submission Program or other mechanisms
  • Statement that the medical device will require an original or supplemental PMA or De Novo submission
  • List of Part A and/or Part B Medicare benefit categories, as applicable, into which the manufacturer believes the medical device falls. (To be eligible for the Parallel Review Program, the medical device cannot be excluded by statute from Part A and/or Part B Medicare coverage.)
  • Statement that the medical device addresses the public health needs of the Medicare population and an explanation of how

In order to be considered for the program, device manufacturers should submit requests, with the above referenced information, by sending an email to: Parallel-Review@fda.hhs.gov. Questions or additional information can be requested through the same email address.

The Federal Register Notice states that “the Agencies intend to prioritize innovative medical devices that will benefit from the efficiencies of the Parallel Review” and that “priority will also be given to medical devices expected to have the most impact on the Medicare population;” therefore, it may be most beneficial to highlight these aspects in the request. The FDA intends to respond to requests within 30 calendar days.

Thus far, only one device has successfully navigated the Parallel Review Program: Cologuard, which is a non-invasive screening test for colorectal cancer. According to the FDA, the Parallel Review Program can cut as much as six months from the time between clinical study initiation and CMS coverage.

If you have further questions regarding the Parallel Review Process, NAMSA’s experts are available to provide insight on how to best navigate the medical device development landscape. Please reach out to us at namsa.com/contact-us.

Authors:

Kristy Katzenmeyer-Pleuss, Ph.D, is a former FDA medical device reviewer and currently a Senior Medical Research Manager, Regulatory at NAMSA. She holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. Her experience includes developing high-level regulatory strategy and policy, facilitating communications and meetings with regulatory agencies, and drafting premarket submissions and deficiency responses. Kristy has experience with a variety of medical device types and combination products, including general and plastic surgery, wound care, dermatologic, cardiovascular, orthopedic, neural, ophthalmic, ENT, dental, respiratory, infection control, general hospital, digital health, etc. She is also a subject matter expert in biocompatibility and reprocessing (reusable and reprocessed single-use devices).