What is an FDA Breakthrough Device Designation?

The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, is responsible for protecting and promoting public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. As part of its mission, the FDA is also responsible for helping speed innovations to market that make medical products safer, more effective, and more affordable.

To help patients receive more timely access to these innovations without compromising safety, the FDA created the Breakthrough Devices Program. This voluntary program was designed to help expedite the development, assessment, and review of breakthrough technologies, while preserving the regulatory standards for premarket approval (PMA), 510(k) clearance, and De Novo marketing authorization.

Launched in 2018, the Breakthrough Devices Program replaced the Expedited Access Pathway and Priority Review for medical devices. Devices granted designation under the Expedited Access Pathway are now considered by the FDA to be part of the Breakthrough Devices Program.

Providing Timely Access to New Medical Breakthroughs

FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This includes devices subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo designation. To be eligible for Breakthrough Device designation, both of the following criteria must be met:

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
2. The device also meets at least one of the following:
   1. Represents breakthrough technology
   2. No approved or cleared alternatives exist
   3. Offers significant advantages over existing approved or cleared alternatives
   4. Device availability is in the best interest of patients

Benefits of the Breakthrough Devices Program

The Breakthrough Devices Program is comprised of two phases. The first is the Designation Request phase, in which an interested sponsor of a device (usually a company) requests that the FDA grant that device Breakthrough Device designation. The second phase encompasses actions to expedite development of the device and the prioritized review of subsequent regulatory submissions.

The Breakthrough Device designation basically allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during premarket development, as well as during the submission process, and then expedited review once the submission for the device is filed.

New Medicare Coverage Pathway Finalized for Breakthrough Devices 

For companies with breakthrough-designated devices, recent changes to how the Centers for Medicare & Medicaid Services (CMS) approaches the reimbursement of these devices is another significant benefit. The Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P) rule finalized January 12, 2021, established a new Medicare coverage pathway that provides Medicare beneficiaries nationwide with covered access to medical devices designated as breakthrough by the FDA. The new MCIT pathway begins national Medicare coverage on the date of FDA market authorization and continues for four years.

Under previous rules, FDA approval of a device was usually followed by a lengthy and costly process to achieve Medicare coverage. The lag time between FDA approval and Medicare coverage has been referred to as the “valley of death” for innovative products. However, under the new MCIT rule, Medicare will provide national coverage simultaneously with FDA approval.

Number of Breakthrough Device Designations in the U.S.

Although the FDA doesn’t make Breakthrough Device designations public (companies can choose to keep their designations private), according to an article published May 27, 2020, nearly 300 Breakthrough Device designations have been granted during the program’s history, including 50 in 2020 as of May 27. In 2019, 136 designations were granted, along with 55 in 2018 , 19 in 2017, and 11 in 2016.

SOLVD Health’s Breakthrough Device Designation for Opioid Use Disorder

SOLVD Health currently holds two of these Breakthrough Device designations. The first was awarded in 2018 for the company’s genetic risk assessment for opioid use disorder (OUD), which is designed to identify patients at increased genetic risk for opioid addiction. The test represents breakthrough technology because it offers higher sensitivity and specificity than other currently used risk assessment tools and is in patients’ best interests because it could help prevent high-risk exposure to oral prescription opioids and subsequent addiction.

Our genetic risk assessment for OUD is currently undergoing expedited review by the FDA. If it receives marketing authorization, it will join a dozen* or so other breakthrough-designated devices that have gone on to achieve final marketing approval.

SOLVD Health’s Breakthrough Device Designation for Detection of Colorectal Cancer and Precancerous Adenomas

The second designation was awarded in 2019 for the company’s test to detect colorectal cancer and precancerous adenomas. The test represents breakthrough technology because it’s the first test to use the gut microbiome to detect precancerous and cancerous lesions in the colon, offers higher specificity and sensitivity for advanced adenomas than other tests currently on the market, and is in the best interest of patients because it could help prevent colorectal cancer through early detection of advanced adenomas.

*as of September 2019