The FDA has issued several updates to its guidance surrounding digital health tool development. The final guidance and two draft guidances were drawn to clarify which technologies are subject to regulatory oversight.
According to FDA Commissioner Scott Gottlieb, MD, the policy documents are part of the FDA’s mission to address digital health products that fall under the umbrella of the 21st Century Cures Act.
“Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review,” Gottlieb says. “And we’re providing more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation. This will allow us to focus our efforts on the highest-risk products.”
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