FDA Policy/General

Digital Health Technologies an FDA Priority: Article

Three CDER and Digital Health Center of Excellence staffers say advancing the use of digital health technologies (DHTs) is a priority for FDA. “We recommend engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results,” the three write in a JAMA Health Forum open-source article.

The article cites a recent FDA guidance on conducting clinical trials with decentralized elements and makes these points:

the agency anticipates that reducing the burden on trial participants will improve trial recruitment, participant engagement, and retention throughout the trial;
using DHTs in clinical investigations may facilitate the inclusion of certain participants with physical or cognitive disabilities or pediatric participants; and
FDA sees the potential for DHTs to capture novel measures that are used to support endpoints in medical product clinical trials.

The paper says the Digital Health Center of Excellence has developed a Digital Health Policy Navigator to help interested parties navigate the digital health regulatory landscape by helping to identify whether their products’ software functions are potentially subject to FDA regulatory oversight as a medical device, and if so, providing considerations that may assist in determining the applicable FDA-specific regulatory requirements and recommendations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome