JD Supra December 29, 2021
On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” (Guidance). The Guidance synthesizes the FDA’s recommendations, based on input solicited from numerous stakeholders over the course of the last six years. Once finalized, the Guidance will directly affect drug, device, and biotech companies, as well as research institutions, that sponsor FDA-regulated clinical investigations incorporating digital health technologies (when used for healthcare related purposes, “DHTs” as defined in the Guidance). It will also affect investigators, research sites, and institutional review boards (IRBs) that conduct or review those clinical investigations. FDA is accepting comments on...