CDRH Industry: FDA Issues International Medical Device Regulators Forum’s (IMDRF) Draft Guidance on Clinical Evaluation of Software as a Medical Device

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled "Software as a Medical Device (SaMD): Clinical Evaluation."  The draft guidance focuses on establishing the scientific validity, clinical performance, and analytical validity for a SaMD.  The draft guidance is intended to provide globally harmonized, risk-based principles of when and what type of clinical evaluation is appropriate for a particular SaMD.

The draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF). IMDRF is a voluntary group of medical device regulators from around the world, including the FDA, who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices. The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence. 

For more information about IMDRF, please see the FDA’s IMDRF webpage.

We welcome your comments and suggestions regarding this draft guidance.  The Federal Register docket for receiving comments will be open for 60 days.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health