FDA seeks revamp of medical devices approvals

The US Food and Drug Administration (FDA) is set to change the way that medical devices are approved, after 42 years.

Scott Gottlieb, commissioner of the FDA, and Jeff Shuren, director of the Center for Devices and Radiological Health, released a statement on Monday, November 26, on plans to modernise the medical device market.

Currently, the US approval process is governed by section 510(k) of the Food, Drug and Cosmetic Act.

Under the 510(k) pathway, manufacturers can pursue an expedited approval process where they can seek to prove that new products are very similar to those already in circulation.

Last year, the FDA approved 3,173 devices through the 510(k) pathway, equating to 82% of the total devices cleared.

But, according to Gottlieb and Shuren, nearly 20% of the approved products were based on a predicate device which was more than a decade old.

While new technologies have “tremendous public health promise for patients”, the advancements also introduce new complexities which can make the review of safety and effectiveness more challenging, they explained.

Gottlieb and Shuren said that they want to change the 510(k) process, while also making it easier for companies to establish new products.

They would like manufacturers to base new products on devices that are not more than a decade old, and may even publicise those who are basing products on older technologies.

“New medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria”, Gottlieb and Shuren said.

They said that the FDA will seek to introduce “additional actions that will allow the FDA to retire outdated predicates”. This new guidance will be finalised in early 2019.

The statement comes after medical journal The BMJ revealed that medical devices which have not been tested adequately, or at all, are in circulation. The reports followed an international investigation into injuries and deaths linked to devices.

Industry group the Advanced Medical Technology Association has hit back at the FDA’s plans, claiming that the ten-year cut off “could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices”.

The association said that the 510(k) pathway has proven its effectiveness over the years, and it will “stand ready” to work with the FDA and other stakeholders to continue improving the process.

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US Food and Drug Administration, Scott Gottlieb, medical devices, health and safety, 510(k), regulation, product approval, technological advancement.



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