The U.S. Food and Drug Administration has released a draft document focused on the requirements for clinical evaluation of software-as-a-medical devices (SaMD).
It aims to “harmonize” U.S. policy with the guidance prepared by the International Medical Device Regulators Forum (IMDRF).
Manufacturers will be required to develop evidence to demonstrate the safety, effectiveness and performance of the SaMD, the guidance states, though it will not replace or conflict with premarket or postmarket regulatory requirements. FDA asks for comment on eight aspects of the guidance, according to an article in Regulatory Affairs Professionals Society.
