“Today, the U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it…”
“Our plan outlined our efforts to reimagine the FDA’s approach to ensure all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we’ve accomplished several key initiatives, including launching and testing the digital health software precertification pilot program (“Pre-Cert”) and taking steps to modernize our policies.”
“The guidances issued today continue those efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies. We’ve taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the intent to provide a practical oversight framework that is risk based.”
“The first guidance we’re announcing, Clinical Decision Support Software, is a revised draft guidance based on careful review of public comments received on the previous draft published in 2017…”
“Also issued today was the final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act which addresses other digital health provisions included in the Cures Act. Specifically, this final guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices under the amended definition of device…” Read the full statement here.
Source: Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight. September 26, 2019. BioSpace.
