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Jan 08

Modernising the Rules on Medical Devices: Breakthrough Designation Program Finalised by FDA

In a bid to modernise and streamline the current regulatory processes surrounding Medical Devices, the US Food & Drug Administration (FDA) have finalised their Breakthrough Devices Program. Breakthrough Designation Programmes are highly beneficial to all patients and healthcare providers involved, because they help to aid and expedite the development, assessment and review processes of medicinal products.

This guidance encourages communication between the FDA and Medical Device manufacturers, and focuses on devices which cater for patients with incurable, life-threatening and/or debilitating diseases. Novel devices used to cure uncommon diseases may be more difficult for the FDA to examine and ultimately approve. Having a Program dedicated to these will offer a specific insight and knowledge, as well as speed up the approval process for them.

Since its establishment in 2016, the Program has approved eight products through the regulatory pathway and given the Breakthrough Designation to a further 110. As a result, patients have been able to gain access to the devices they need in a more timely fashion, with the safety standards of such products also continually improving.

Owing to modernisation efforts, the FDA have updated their 510(k) regulatory approval pathway, to revamp the approval process for new devices that have the same intended use and technological characteristics as an existing (legally marketed) device. They have also amended their DeNovo Clearance review process, encompassing products with safety profiles and technology that are reasonably well-understood, despite never having been marketed in the US.

Device manufacturers can apply for the designation by submitting a “Designation Request for Breakthrough Device” Q-Submission to the FDA. It may be advised that manufacturers also check the device eligibility criteria before applying.

The FDA hopes to enforce its Safer Technologies Program (STeP) at some point next year. Similar to the Breakthrough Designation Program – ultimately, to improve patient safety and speed up current regulatory processes – only it focuses on devices used to treat non-life threatening conditions.

For more information about the FDA’s Breakthrough Designation Rule, please visit the following article published by MedCity News.

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