The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
The U.S. Food and Drug Administration designated 213 submissions as breakthrough devices in 2021. This is, by far, the most designations awarded in a single year and increases the total of devices designated in all of the preceding years since the program began by 50 percent.
The FDA Breakthrough Devices Program
FDA review protects the public from unproven and potentially dangerous medical products. The downside is that the approval process delays badly needed novel products from reaching the market. The Breakthrough Devices Program is designed to resolve this process by providing an expedited approval process for novel medical devices and device-led combinations that provide for more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. Breakthrough device designation is available to devices subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo designation.
The Breakthrough Devices Program is comprised of two phases. In the first, or designation request phase, device companies (or other sponsors) request that the FDA grant the device Breakthrough Device designation. In the second phase, companies collaborate with FDA officials to validate the device’s safety and efficacy on an expedited and prioritized review basis.
Drip, Drip, Drip, Gush—The Program in Action
Up to now, program results have been less than dramatic. A grand total of 11 devices received breakthrough designation in 2016, the first full year in the program’s history. That total climbed to 19 in 2017, 55 in 2018, and 71 in 2019. But breakthrough business has picked up significantly in the last three years, culminating in 2021 where results “far exceeded” expectations. Key numbers, cited in the new FDA, Center for Devices and Radiological Health (CDRH) report:
Of the 13 novel devices authorized as breakthrough devices in 2021, there were three PMAs, three 510(k)s, and seven De Novos. Novel devices, breakthrough and otherwise, that received marketing authorization during the year:
Paige Prostate, the first software based on artificial intelligence (AI) designed to identify an area of interest on the prostate biopsy image most likely to harbor cancer;
GI Genius, a device that uses AI based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in real time during colonoscopy;
Cognoa ASD Diagnosis AID, a machine learning-based software to diagnose autism spectrum disorder in children 18 months through five years of age who exhibit potential symptoms; and
Shockwave Intravascular Lithotripsy (IVL) System for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries before stenting.
Here are some of the key new FDA EUAs and clearances that were announced starting in late January 2022:
New FDA Emergency Use Authorizations (EUAs) & Approvals
Manufacturer(s)
Product
Streck
Clearance for MDx-Chex for BCID2 to verify performance of BioMérieux BioFire Blood Culture Identification 2 panel for sepsis
BioFire Defense
510(k) clearance for BioFire Defense COVID-19 Test 2
Maxim Biomedical
EUA for MaximBio ClearDetect COVID-19 Antigen Home Test for over-the-counter use
Mammoth Biosciences
EUA for DETECTR Boost SARS-CoV-2 Reagent Kit, a high-throughput SARS-CoV-2 assay utilizing CRISPR technology with PCR-equivalent performance
Diadem
Breakthrough device designation for AlzoSure Predict blood-based biomarker prognostic assay for early prediction of Alzheimer's disease
iHealth
EUA for iHealth COVID-19 Antigen Rapid Test Pro
Pathogenomix
Breakthrough device designation for Patho-Seq assay
