Food and Drug Administration Commissioner Scott Gottlieb, MD, detailed new plans the agency will to take towards regulating the digital health market in a June 15 blog post on the FDA website.
The FDA plans to specify its regulatory role under the 21st Century Cures Act and will introduce a "Digital Health Innovation Plan," which the agency hopes will spark innovation in digital health as the market grows at a rapid rate, Dr. Gottlieb wrote.
For new technologies to prosper, Dr. Gottlieb said "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."
Although a major advancement in clarifying digital health regulation, 21st Century Cures Act is not enough, Dr. Gottlieb wrote. The FDA will publish further guidelines in the next few months to establish what technologies fall outside the scope of FDA regulations, to ensure new technologies do not have to be considered on a case-by-case basis.
The FDA is also developing a pilot of a third-party certification and assessment 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."
Dr. Gottlieb concluded the FDA's increased focus on digital health products will help innovators navigate the regulatory process more quickly and effectively.
"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." he wrote.
Click here to read the blog post.
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