FDA hopes draft guidance on device software will offer clarity, simplicity
Summary
WHY IT MATTERS The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions. "We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary consensus standards, once finalized," he added. THE LARGER TREND Speaking a year ago about the promise and potential for medical technology, especially as artificial intelligence and machine learning evolve, Patel made note of FDAs total product life cycle approach to AI-powered software-as-a-medical devices. The goal, he said in October 2020, was that "FDA oversight would provide the level of trust and confidence to the users, at the same time leveraging transparency and pre-market assurance, as well as ongoing monitoring of those products that are learning on the fly. "The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices."