New York Times calls for tightened medical device regulation from FDA

Monday, May 6, 2019

Source: MassDevice

The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use.

The paper’s editorial board 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.

The Times goes on to voice its support for improved post-market surveillance, claiming that while industry proponents advocate for earlier commercialization followed by rigorous post-market testing, many companies that have followed that route fail to complete the studies, even under FDA order.

“What’s more, device makers frequently skirt rules requiring them to report publicly all incidents of malfunction, injury or illness – often through mechanisms the FDA itself created,” the Times wrote. “And after years of wrangling, the industry and its regulators have still not fully put a system in place to better notify patients of product recalls and other safety issues.”

While the federal watchdog has vowed to fix some of these issues, the editorial board said that more could be done by the agency to improve post-marketing monitoring.

In its last point, the Times urges the FDA to widen the separation between itself and the device industry, citing the fact that the industry funds 35% of the office’s work, that top positions at the FDA are often used as launching boards to lucrative industry gigs and that medtech lobbyists spent more than $300 million in the 10 years leading up to 2017.

The Times also called attention to the fact that the medtech industry pays doctors and hospitals hundreds of millions of dollars in consulting fees every year. Despite the fact that these payments do not violate any rule of law, the payments create an environment where lines are blurred, the paper argues.

“Medical institutions and professional societies should establish, or amplify, guidelines discouraging such payments. Stronger laws that provide more funding for the work of device regulation — so that the F.D.A. is not as reliant on industry dollars — would also help the agency to fulfill its mission,” the Times wrote in its report.

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