On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. The framework builds upon FDA’s draft guidance, DHT remote acquisition of clinical trial data (December 2022), and is a step toward fulfilling FDA’s commitment under the Prescription Drug User Fee Act VII (PDUFA VII) to clarify its stance on DHTs’ use in drug, device, and biologics product development. While the framework is not an official guidance document and does not establish policies, it provides important insight into the FDA plans to regulate this area.
FDA Regulatory Framework
FDA’s framework proposes internal and external programs that will address the development and use of DHTs. Internal programs include a DHT steering committee with senior staff from the Center for Biological Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH) (collectively called the “Centers”) to help evaluate DHT-based data in drug and device approval applications and device clearances.