Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile health app regulation.
In a blog post published this morning, Gottlieb laid out a plan that includes clearer articulation on which devices require FDA clearance, as well as a potential firm-based approach to FDA clearance and a proposal to use postmarket data in the regulation of health apps.
"For these ... digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation," Gottlieb wrote. "In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures. To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development."
Gottlieb reminded readers that the recently passed 21st Century Cures Act takes some categories of mobile medical app outside the FDA's purview, such as clinical administrative support software and wellness and lifestyle apps. He said the FDA will publish guidelines that clarify the exact boundaries of this low-risk category, and, furthermore, intends to add some classes of apps not mentioned in the bill to the sphere of nonregulated devices.
He also laid out plans for a third-party certification program that would function sort of like TSA pre-check for FDA clearance.
"While the pilot program is still being developed, 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," he wrote. "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."
Finally, Gottlieb said the FDA would work with Medical Device Innovation Consortium (MDIC), a public-private partnership, to investigate using MDIC's National Evaluation System for health Technology (NEST) to streamline clearance for new devices and device updates.
FDA expert and Epstein Becker Green partner Bradley Merrill Thompson told MobiHealthNews in an email that this new direction is welcome news for him and many others in the industry who have long been frustrated by a lack of clarity from the agency.
"Since 2011, the CDS Coalition has been asking – indeed begging at times – for FDA to publish guidance that clarifies the scope of the agency's regulation of clinical decision support software," he wrote. "During the winter, after 21st Century Cures was signed into law, but before Dr. Gottlieb took over, FDA seemed still unsure what to do. Now FDA seems to be committing to publishing guidance in the coming months to clarify, beyond the legislation, what FDA will regulate in the area of clinical decision support and other such software. That is music to my ears."
Thompson noted that Clinical Decision Support Coalition, an organization he is involved in the leadership of, has gone as far as to submit a citizen's petition requesting this clarity. That petition includes a wish list of topics for FDA to address, including software associated with pharmaceuticals and, eventually, artificial intelligence. He's also supportive of the new clearance pathway.
"In the blog post, Commissioner Gottlieb also seems to reference the discussions that industry has been having lately with FDA regarding adoption of the TSA pre-check idea as a better way of bringing new software to market," Thompson wrote. "The blog post suggests that the agency is committed to this approach, which obviously we are delighted to hear. There is much good that can be done, although there is much work left to be done. It will be very important to get the details right."
FDA has been talking lately about the creation of a new office of digital health funded by medical device user fees. Gottlieb didn't mention that office in the blog post, but the two ideas are certainly compatible, since the development of a novel clearance pathway will require considerable staffing power.
