FDA acts to expand access to COVID-19 therapy

Apr 07, 2020 - 04:15 PM

The Food and Drug Administration recently issued an enforcement policy allowing certain modifications to expand the availability of devices used in extracorporeal membrane oxygenation therapy during the COVID-19 public health emergency. The policy will allow for device modification without requiring certain premarket notifications and applications, where such modification does not create an undue risk.

Related News Articles

Headline
CDC report finds COVID-19 vaccine for children reduced chances of ED, urgent care visits
The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing…
Headline
AHA responds to FDA request for information on AI-enabled medical devices
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
Permanent recall issued for Baxter ventilation system
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
CDC data shows rise in flu, COVID-19 cases across states 
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
Recall issued for mislabeled potassium chloride
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
Study finds flu, COVID-19 infection temporarily raises risk of heart attack, stroke 
A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19…