Health IT, Devices & Diagnostics

FDA Commissioner lays groundwork for digital health innovation plan including certification program

In a blog post this week, Scott Gottlieb highlighted the Digital Health Innovation Plan that will clarify how the FDA regulates digital medical devices and apps.

The U.S. Food and Drug Administration Commissioner Scott Gottlieb offered a preview of a new Digital Health Innovation Plan in a blog post this week. It will clarify how the FDA regulates digital medical devices and apps. It is a significant development since it shows that the FDA will play a more active role than it has done as the private sector have pushed ahead with their own forms of vetting initiatives from Mount Sinai’s app prescription platform to Apple’s tightened health app criteria.

In the blog post, Gottlieb said the FDA will provide guidance to clarify its position on products that contain “multiple software functions”. He also noted that new guidance will clarify the software that is a low enough risk that the FDA won’t subject them to pre-market requirements.

Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.

Gottlieb said this fall the regulator would be rolling out a “comprehensive approach” to regulating digital health tech.

…we are considering whether and how, under current authorities, we can create a third party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review. Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.

He also talked about how post-market data collection from this software could be used with EHR and claims data collected through the National Evaluation System for health Technology (NEST) to both speed up market entry and add more indications for digital health tools.

 In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government. Although FDA does not own or operate NEST, we have been establishing strategic alliances among data sources to accelerate NEST’s launch with the initial version of a fully operational system anticipated by the end of 2019.

Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources.

Although Gottlieb’s blog post sought to clarify the regulator’s digital health strategy, there was no reference t0 plans for the digital health unit described by Bakul Patel, Associate Center Director for Digital Health at FDA, in an interview with Wired last month, as MobiHealthNews noted.

 

Photo: NicoElNinom, Getty Images

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