Devices & Diagnostics

FDA finalizes new breakthrough device designation rule

The larger regulatory modernization efforts, which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA's Medical Device Safety Action Plan.

As part of the Food and Drug Administration’s effort to modernize the regulatory pathways around medical devices, the organization has finalized guidance around its breakthrough device designation and has announced plans to launch its Safer Technologies Program (STeP).

The modernization efforts which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA’s Medical Device Safety Action Plan, which is meant to strengthen guardrails for patient safety while still providing a pathway for innovative medical devices to get to market.

The Breakthrough Device designation was instituted in 2016 and is meant for products that are meant to address or diagnose life-threatening or irreversibly debilitating conditions. Since the program has been introduced, 110 devices have received the designation and eight products have received approval through the regulatory pathway.

Benefits from the Breakthrough Device designation include early and more frequent contact with the FDA in an effort to collaborate and streamline development and regulatory approval. The idea being that breakthrough devices are often complex or novel solutions which can be difficult for the FDA to judge and examine.

The updates being made to the program follow in the same vein and include ways to improve the efficiency of the regulatory process through more effective consultation between device makers and the FDA.

These include sprint meetings which can be called to address specific issues and more feedback on testing and clinical protocols.

While devices that receive the breakthrough designation will still need to meet the high premarket approval standard of safety and effectiveness, the FDA said it is willing to “accept a greater extent of uncertainty of the benefit-risk profile for these devices” dependent on the post market controls and the need for patients to have earlier access to the device.

In its preview of the Safer Technologies Program – which is expected to get fleshed out over the next year – the FDA said it plans to apply principals and features of the Breakthrough Devices Program to devices which represent significant safety improvements than existing alternatives.

The program is being created to speed up the process for innovative and safer devices that treat conditions not considered to be life-threatening or irreversibly debilitating and therefore meet the Breakthrough Devices criteria.

“We believe that (both programs) could have similar impact in spurring the development of and give patients more timely access to important medical devices,” FDA commissioner Scott Gottlieb, and Jeff Shuren, director of the Center for Devices and Radiological Health, wrote in a statement.

“If the same programmatic benefits that encourage device manufacturers to create devices to treat or diagnose a life-threatening disease could be applied to bring innovation to medical device safety for less serious conditions, the potential public safety impact could be tremendous.

Credit: NicoElNinom, Getty Images

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