FDA Plans to Revisit Regulations for Digital Health Products

The U.S. Food and Drug Administration (FDA) has announced its intention to revisit its current regulatory approach to digital medical devices, including mobile medical applications.

According to a June blog post on the FDA website by FDA Commissioner Scott Gottlieb, the agency is currently considering the creation of “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.” The certification program could be part of a pilot program slated to be launched by the FDA this fall, according to Gottlieb.

In addition, Gottlieb noted that his agency is also investigating the potential for the post-market collection of real-world data that could be used to expedite future FDA registrations, as well as in support of new and evolving product functions.

“Through these and other steps,” Gottleib concluded in his blog post, the “FDA will help innovators navigate a new modern regulatory process so that promising, safe and effective developments in digital health can advance more quickly and responsibly.”

Read the complete text of Commissioner Gottlieb’s blog post on the future regulation of digital health products.

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