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.
Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.
The guidances issued 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.
The first guidance we’re announcing, Clinical Decision Support Software, is a revised draft guidance based on careful review of public comments received on the previous draft published in 2017.
After first publishing the draft guidance in 2017, the agency received feedback from many stakeholders advising us on improvements that could be made to better clarify the agency’s oversight of CDS products.
In this draft guidance, it is propose to focus the regulatory oversight on CDS functions that are intended to help health care professionals and patients inform their clinical management for serious or critical conditions and that are not intended for health care professionals to independently evaluate the basis of the software’s recommendations Overall, these important guidance documents being issued today expand on our efforts to both encourage innovation in the ever-changing field of digital health and protect the public health.
Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation according to the Cures Act.
These documents are critical elements of FDA’s comprehensive approach to digital health. We are committed to promoting beneficial innovation in this space while providing appropriate oversight where it’s merited.
