FDA: Device Breakthrough Program Exceeds Expectations, While New Device Approvals Drop in 2

Posted on February 01, 2022 | By Joanne S. Eglovitch

In its 2021 annual report, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said it had cleared, approved, or cleared a record 13 devices with Breakthrough Status. , although the number of new devices it has licensed has fallen from its peak last year.

The report also examines the center’s actions to address device shortages, with new funding from Congress, as well as its response to the COVID-19 pandemic, patient engagement and device safety.

Revolutionary devices

According to the report, the Breakthrough Devices program has “grown significantly” since 2018 and “far exceeds expectations for Breakthrough Designation and Authorization application volumes.”

The agency has granted Breakthrough Designations to 213 devices in 2021, for a total of 617 Breakthrough Designations since the program began in 2015. Of these, 13 Breakthrough Applications have received marketing clearance: three premarket approval requests, 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 aids in rehabilitation. stroke patients with an upper limb or hand or wrist and arm disability.

Use of the Breakthrough Devices pathway has grown steadily since its inception, with just 11 designations in 2016 and 138 in 2019, according to an analysis conducted by Brigham and Women’s Hospital and Harvard Medical School in Boston. (RELATED: Review: FDA device approval pathways more complex than everRegulatory guidance August 3, 2021)

In other areas, CDRH approved 103 new devices in 2021, calling it an “incredible achievement” due to increased staffing demands due to the COVID-19 pandemic. Still, the number of new devices approved has fallen from a record 132 devices approved in 2020, according to CDRH Director Jeffrey Shuren’s announcement last year.

Examples of new devices approved last year include a shock wave 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 steps taken to increase the resilience of the medical device supply chain. The report says the $21.6 million approved by Congress last year for a new Resilient Supply Chain and Shortage Prevention Program (RSCSPP) will allow the center to “provide resources to establish a program resilience of the American supply chain 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 national supply chain through investments in preventive measures, identifying potential supply shortages of medical products, continuing surveillance and rapid intervention.

Other steps the agency is taking to address drug shortages include maintaining a public list of medical device shortages and working with more than 1,000 manufacturers and suppliers in more than 12 countries to monitor shortages in the supply chain.

The agency also conducted 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 approximately 130 employees to work full or part time in the event of a shortage.

CDRH Annual Report

© 2022 Society of Regulatory Affairs Professionals.


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