The U.S. Food and Drug Administration (FDA) has published its final Guidance on the qualification of tools for evaluating medical devices.
Published in mid-July, the Guidance, “Qualification of Medical Device Development Tools,” describes a voluntary program for the qualification of medical device development tools (MDDTs) used in the evaluation of devices regulated by the Administration’s Center for Devices and Radiological Health (CDRH).
According to the Guidance, MDDTs are “a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device.” Some examples of MDDTs include non-clinical assessment models (NAMs), biomarker tests (BTs), and clinical outcome assessments (COAs).
The CDRH says that the use of MDDTs will help to “facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting information to support regulatory submissions.”
Guidance documents issued by the FDA are intended only to represent the current thinking of the agency and are not binding on either the FDA or the public.