facebook linkedin twitter

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.”

Loud Climate Policy

Let me set the stage: There’s a Democratic majority in both houses of Congress and a Democrat in the White... Read More

Let me set the stage: There’s a Democratic majority in both houses of Congress and a Democrat in the White House. Climate advocates have spent the last few years in the exile of a Republican Administration, one quarter drawing more and more attention to hurricanes and... Read More

October 15, 2021
by Reece Nations
Tech Innovation ‘Fundamental Foundation’ of Feasibly Solving Climate Crisis

WASHINGTON -- The foundations of what could prove to be the next great innovations in climate change prevention technology were... Read More

WASHINGTON -- The foundations of what could prove to be the next great innovations in climate change prevention technology were laid out and dissected during a Brookings Institution webinar this week. Sanjay Patnaik, director of Brookings Center on Regulation and Markets, hosted a virtual discussion on... Read More

October 15, 2021
by Reece Nations
Texas Removes LGBTQ Youth Suicide Hotline After Primary Challenger Goads Abbott

AUSTIN, Texas — The Texas Department of Family and Protective Services has taken down a webpage that offered resources to... Read More

AUSTIN, Texas — The Texas Department of Family and Protective Services has taken down a webpage that offered resources to LGBTQ youth after criticism was leveled at Gov. Greg Abbott by a primary challenger for its inclusion. Former Texas state Sen. Don Huffines, who announced his... Read More

October 15, 2021
by Victoria Turner
Panelist Says Counterfeit Goods a 'Globalized Business’

WASHINGTON -- If you do a quick Google search for fake Apple Airpods, an almost endless list of options will... Read More

WASHINGTON -- If you do a quick Google search for fake Apple Airpods, an almost endless list of options will come up, said Piotr Stryszowski, senior project manager at the Organization for Economic Development and Cooperation, Thursday.  Not only does the counterfeit problem affect the U.S.... Read More

FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after... Read More

Report: Offshore Wind Supply Chain Worth $109B Over 10 Years

ATLANTIC CITY, N.J. (AP) — A group studying the economics of offshore wind energy in the U.S. says building and... Read More

ATLANTIC CITY, N.J. (AP) — A group studying the economics of offshore wind energy in the U.S. says building and operating the nascent industry will be worth $109 billion to businesses in its supply chain over the next 10 years. The report by the Special Initiative... Read More

News From The Well
scroll top