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Could save firms millions

FDA proposing new fast track for medical device approval

by Thomas Dworetzky , Contributing Reporter
The U.S. Food and Drug Administration is proposing a “fast track” for certain medical devices, as well as cuts to the safety data needed for agency approval.

It is the agency's “intention to propose an alternate approach to the traditional 510(k) clearance process, which will involve the use of modern, science-based, consensus standards and FDA-developed performance criteria as the comparator for device review for certain well-understood technologies,” FDA commissioner Dr. Scott Gottlieb wrote in the official FDA blog.

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At present, he pointed out, the agency compares new devices to prior ones, called predicates, that can be as much as 40 years old. In order for a new device to gain 510(k) clearance it must have moderate risk and be “substantially equivalent” to one that already exists.

Basically, the new alternative to predicates makes them replaceable by a different approach that uses benchmarks of performance standards and guidance documents — the plan, according to Reuters, would be voluntary.

“Today, in new draft guidance on the Least Burdensome Provisions, FDA defines least burdensome to be the 'minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.' The new draft guidance also explains FDA’s regulatory approach and delineates guiding principles that we propose to apply across the total product life cycle — beyond what Congress has required — including all device-related applications and interactions with the medical device industry,” Gottlieb wrote in the agency blog post.

The alternative path could save firms millions of dollars and save substantial time in bringing new products to market.

The approach also supports President Trump's call to slash regulations and has garnered support from makers.

Industry group AdvaMed “commends FDA’s commitment to promoting patient access to medical technologies through innovative regulatory pathways,” its spokeswoman Janet Trunzo told Reuters.

Gottlieb also addressed the issue of high-risk products and stated that the agency would look to speed up their approval as well — and plans to issue new guidance that will lay out “how certain issues could be ultimately resolved in the postmarket setting, rather than the premarket setting, to allow patients to gain faster access to potentially lifesaving devices.”

Dr. Rita Redberg, a cardiologist at the University of California San Francisco and editor of JAMA Internal Medicine, raised concerns to the news agency, however, arguing that the moves could put safety issues from premarket to postmarket — and possibly risk patients' health.

“When we use devices on patients without clinical studies first, the patients effectively become the trial and the insurers become the funder of the device trial,” she advised.

Others in the health care community also chimed in about the potential easing of premarket testing.

“I see a potentially huge problem in moving more risk to the post-approval setting,” said Areta Kupchyk, a partner at Foley Hoag and former associate chief counsel at the FDA. “It’s very difficult once a product has been approved to pull it back.”


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