ITHS REMOTECH FDA Resources
Welcome to the University of Washington ITHS REMOTECH FDA Resources page. This page provides links to/summaries of various FDA resources related to common FDA regulatory questions that clinical researchers may have about the use of remote technology in research.
The information and resources on this page are educational in nature and are not intended to constitute legal advice, nor do they establish an attorney-client relationship between a clinical researcher or other interested party exploring these resources and any attorney who represents or provides such advice to the University of Washington. Individual users of this page are responsible for their own regulatory compliance with respect to the use of remote technology in clinical research.
FDA’s Role Related to Remote Technology in Research
The FDA is technically not a “Common Rule” agency with respect to research (see below for Common Rule resources); it has its own set of research regulations that must be followed when applicable. This research jurisdiction, however, is limited to research that involves an FDA “test article,” i.e., a drug, device, or biologic that is 1) “investigational” (not approved—or cleared, in the case of most 510(k) devices — as may be required by FDA regulations), and 2) intended for marketing. In addition, in the device arena, the FDA would be involved in regulating research for an investigational device only if the IRB deems the device to be of SR (Significant Risk) in the setting of the proposed research (the FDA would still regulate the device itself in terms of pre-market and post-market requirements). In the digital health technology arena, however, the FDA does offer guidance that can be helpful in areas of clinical research incorporating remote digital technology even though the research does not involve an FDA test article.
