FDA Pilot Project Aims at Quick Approvals for Medical Software

FDA fast-track is good news for health tech

The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company.

"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products", said Dr. Gottlieb. Similarly Apple is now working with Stanford clinicians to research how the Apple Watch could detect abnormal heart rhythms, something that would most likely require FDA approval if it were to diagnose.

"We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate", FDA Commissioner Scott Gottlieb said in a statement reported by Bloomberg.

Officially dubbed the Pre-Cert for Software Pilot, Gottlieb at the time called it "a new and pragmatic approach to digital health technology".

Two months after outlining a precertification program to speed the approval of digital health software, the FDA has announced the 9 companies that will participate in the pilot program, which include tech industry giants, software startups, and pharmaceutical manufacturers. The pilot program will focus on looking at the software developer or digital health developer first, instead of traditionally looking primarily at the product. Apple, for example, has tended to partner with existing health researchers and companies such as DexCom Inc, a conventional medical device firm, for uses of their products that involve regulatory oversight.

As part of the program, the FDA will take a close look at Apple and the other eight companies. They may even not have to submit a product for premarket review in some cases.

"We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program", Park said in a statement today. Fitbit will bring to the program its expertise in evidence-based innovation and in developing engaging experiences and tools that help motivate and inspire consumers to make behavior changes that can help improve health outcomes.

"We previously said that the digital health pilot will include nine companies".

According to the FDA, the companies will now provide the agency access to measures they currently use to develop, test, and maintain their software products, including ways in which they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and to provide information about their quality management system. The FDA wrote that it will welcome input from the pilot participants and other interested parties throughout the duration of the pilot, and plans to hold a stakeholder workshop in January 2018.

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