The New York Times has released an editorial calling on FDA to improve medical device regulation, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use.
The paper’s editorial board on Friday called for the tightening its approval standards, going as far as to support an earlier call from the Institute of Medicine to abolish the 510(k) pathway, which approves devices based on their similarity to existing devices and requires no human testing.
“It’s past time for the agency to heed the advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested,” the NYT editorial board wrote.