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FDA poised to start digital health pilot

Forms a key part of the agency's new digital innovation action plan

US Food and Drug Administration FDA

The FDA will later this month begin pilot tests of a new, pragmatic way of evaluating digital health products that could see them approved more quickly than at present.

Run by the agency’s Center for Devices and Radiological Health (CDRH), the scheme could also replace the need for a premarket submission in some cases and allow for decreased submission content.

FDA commissioner Scott Gottlieb said: “Historically, healthcare has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that’s been cited, among many, is the regulation that accompanies medical products.

“But momentum toward a digital future in healthcare is advancing. Not all of these tools are subject to FDA regulation. For the devices we are asked to evaluate, we know that our policies must continue to empower consumers and facilitate innovation.”

The voluntary Software Precertification Pilot Program will involve nine companies, from start-ups to large firms, and fits within the Digital Health Innovation Action Plan the FDA released in June.

The Plan is the FDA’s vision for how it will regulate digital health technologies that are considered to be medical devices, and how it will provide greater clarity on which types of digital health technology are subject to regulation.

The agency says it “recognises that an efficient, risk-based approach to regulating digital health technology will foster innovation of digital health products”.

But notes that its traditional approach to moderate and higher

risk hardware-based medical devices is “not well suited for the faster iterative design, development, and type of validation used for software-based medical technologies”.

Acknowledging the need for a new approach, the FDA wants to build on its five-year-old Digital Health Program, while updating its policies and processes.

“We’re telling consumers and the digital health industry how we will establish clear and consistent expectations for the products FDA regulates,” Gottlieb said.

Another element of the Plan will see a recruitment drive to build the FDA’s ‘bench strength and expertise’ within the CDRH’s digital health unit.

To do this the agency will recruit a “cadre of experts with a deep understanding and experience with software development and its application to medical devices”.

They will be augmented by a forthcoming CDRH Entrepreneurs in Residence programme. Due to be launched in the autumn, this will involve ‘thought leaders’ and others with experience in software development.

8th September 2017

From: Regulatory

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