The FDA has released a new draft guidance that outlines how developers should evaluate software used for the clinical management of patients.
This software, called "software as a medical device," is not part of a hardware medical device and does not come into direct contact with patients; however, it may analyze data used to inform clinical decisions and patient care. The guidance, which was drafted by the International Medical Device Regulators Forum, provides recommendations for how developers can prove the effectiveness, performance and safety of this software.
The draft guidance emphasizes that it "is not meant to replace or conflict with pre-market or post-market regulatory requirements related to the regulatory classification of SaMD in different jurisdictions."