FDA Greenlights Record Number of Medical Devices

February 18, 2021 by Daniel Mollenkamp

WASHINGTON – In a public health milestone, the Food and Drug Administration announced on Tuesday that it approved a record setting amount of novel medical devices in 2020. 

In 2020, the FDA’s Center for Devices and Radiological Health gave the green light to 132 new devices, which the agency described as “capping off” ten years of growth. 

In 2010, by comparison, the agency had only approved 29 devices, and in 2019, they had only approved 71. 

These new figures broke the previous record from 2017, which had been a 40-year record for the institution, showing a consistent increase in activity that has made the FDA a force in the background of American life. 

Despite the framing of the FDA’s written comment, which proclaimed that the agency has encouraged new levels of innovation “despite” the coronavirus, some of the devices would seem to be deeply connected to the virus. 

The figures included devices permitted under the “Emergency Use Authorization,” which in emergencies allows devices that might otherwise be kept from the market, as well as new uses which might be banned for devices already on the market. 

Secretary of Health and Human Services Alex Azar declared a public health emergency over coronavirus in January 2020.   

The agency has since issued numerous emergency authorizations for personal protective equipment. They have also relaxed regulations surrounding equipment such as ventilators, along with similar attempts to streamline the path to market during the public health crisis such as embracing digital health technologies. 

In fact, the FDA has had to take a more relaxed approach to regulations in general since the coronavirus, not merely on medical device approval. Observers have warned that this situation will need to be revisited after the coronavirus crisis is over because while faster approval processes may offer expediency, it might run the risk of lessening patient safety. 

For now, the agency’s attention is more centered on coronavirus than on policy tradeoffs.

“In 2021, work related to COVID-19 will remain our top priority,” CDRH Director Jeff Shuren said in a written statement.

“Although it is impossible to predict with certainty what the future will bring and whether the innovation pipeline in the U.S. will remain strong, CDRH will continue to adapt and shift resources to best protect and promote the public health.”


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