FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021

Regulatory NewsRegulatory News | 01 February 2022 |  By 

In its 2021 annual report, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said that it cleared, approved or authorized a record 13 devices with breakthrough status, though the number of novel devices it authorized fell from its peak last year.
The report also discusses the center’s actions to address device shortages, thanks to new funding from Congress, as well as its COVID-19 pandemic response, patient engagement and device safety.
Breakthrough devices
According to the report, the Breakthrough Devices Program has “expanded significantly” since 2018 and is “far exceeding expectations for breakthrough designation request and authorization volumes.”
The agency granted breakthrough designations to 213 devices in 2021, for a total of 617 total breakthrough designations since the program began in 2015. Out of those, 13 breakthrough requests received marketing authorization: three premarket approval applications, three 510(k)s and seven de novo requests.
CDRH said the 13 devices “represent a range of intended uses and span regulatory pathways,” and include the world’s first non-surgical heart valve and a brain-computer interface (BCI) device that assists in rehabilitation for stroke patients with an upper extremity or hand or wrist and arm disability.
Use of the Breakthrough device pathway has increased steadily since its inception, with just 11 designations in 2016 and 138 in 2019, according to an analyses conducted by Brigham and Women’s Hospital and Harvard Medical School, Boston. (RELATED: Review: FDA device approval pathways more complex than ever, Regulatory Focus 3 August 2021)
In other areas, CDRH approved 103 novel devices in 2021, calling this “an incredible achievement” due to increased demands on staff due to the COVID-19 pandemic. Yet the number of novel devices approved decreased from a record 132 devices authorized in 2020, according to CDRH Director Jeffrey Shuren’s announcement last year.
Examples of novel devices approved last year include a shockwave intravascular lithotripsy (IVL) system for low-pressure balloon dilation of severely calcified coronary arteries prior to stenting and the first software system based on artificial intelligence to identify an area of interest on the prostate biopsy image most likely to harbor cancer.
Targeting drug shortages
The agency also highlighted the steps being taken to increase the resilience of the medical device supply chain. The report said that the $21.6 million approved by Congress last year for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) will allow the center to “provide resources to establish a permanent program for U.S. supply chain resilience for medical devices.”
According to the report, “the program will build on the work done to implement the CARES Act during the COVID-19 public health emergency, focusing on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply shortfalls, continuing surveillance and rapid intervention.”
Other actions the agency is taking to address drug shortages include maintaining a public medical device shortage list and is working with over 1,000 manufacturing and suppliers in more than 12 countries to monitor supply chain shortages.
The agency has also performed more than two dozen shortage assessments based on signals from manufacturers and distributors related to personal protective equipment (PPE), COVID-19 testing products and ventilators.
In addition, CDRH has reassigned roughly 130 employees to work full or part time on shortages.
CDRH annual report


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