FDA introduces "pre-certification" pilot programme for digital health companies

FDA commissioner Scott Gottlieb on Thursday announced a pre-certification pilot programme that aims to speed up the approval process for medical software companies and products that are deemed less risky than traditional medical devices. He stated that through the Pre-Cert for Software Pilot, the FDA seeks to develop "a new and pragmatic approach to digital health technology" that takes into account "the unique characteristics of digital health products and the marketplace for these tools." 

The agency acknowledged that its usual approach to moderate- and higher-risk, hardware-based medical devices "is not well suited for the faster and iterative design, development and validation used for software products." The FDA explained that under the voluntary pilot programme, which will initially allow up to nine companies to take part, the regulator will first look at the software or digital health technology developer, "rather than primarily at the product, which is what we currently do for more traditional medical devices." Initial participants will range from small startups to large companies that develop both high- and low-risk software products that are devices.

Gottlieb noted that "historically, healthcare has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life…but momentum toward a digital future in healthcare is advancing." He added that "for the devices we are asked to evaluate, we know that our policies must continue to empower consumers and facilitate innovation." 

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According to the FDA, the goals of the programme are to enable a modernised approach that permits software iterations and changes to occur in "a timely fashion," while also ensuring that the quality of medical product software remains high throughout its lifecycle by allowing firms "to demonstrate their embedded culture of quality and organisation excellence."Further, the agency said the initiative will seek to learn and adapt, as well as adjust its elements and measure based on the programme's effectiveness. 

"We have intentionally left the initial [participation] criteria broad because this pilot is purposely designed to be inclusive and flexible," Gottlieb explained, adding "we appreciate that the experience and capabilities of a small company will be different from that of a large company and recognise that we need a pre-certification programme that accommodates both."

The pilot programme is part of the FDA's broader digital health innovation plan unveiled in June that the agency said would feature a new post-market approach regarding the regulation of digital medical devices. For related analysis, see ViewPoints: The FDA's first steps toward digital health shouldn't be its last.

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