June 15, 2017

FDA Announces New Initiatives to Regulate Digital Health Technologies

Holland & Knight Healthcare Blog
Michael J. Werner

U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb, M.D., posted a blog on June 15, 2017, announcing new FDA initiatives to be piloted this fall regarding the regulation of digital health technologies. Gottlieb said that the agency is considering whether and how it can establish 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." Details are still being worked out, but Gottlieb noted that certification could be used to assess whether a company "consistently and reliably" engages in high quality software design and testing as well as ongoing maintenance of its software products.

Gottlieb also said the FDA will use collection and analysis of real-world data (data gathered outside of clinical trials or controlled studies) by product developers to meet post-market commitments. He also noted that FDA is working to implement the digital health provisions of the 21st Century Cures Act and will be publishing guidance to further clarify what falls outside the scope of FDA regulation as well as to explain how the new statutory provisions affect pre-existing FDA policies.

In addition, Gottlieb gave a status report on other relevant guidance, saying that FDA is developing guidance to clarify its position on products that contain multiple software functions, where some fall outside the scope of FDA regulation but others do not. Gottlieb said that the agency also will develop new guidance on other technologies that present low enough risks that FDA does not intend to subject them to certain premarket regulatory requirements.

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