The FDA’s Vision For Medical Devices Is Coming To Life


James Cohen and Michael Ryan co-authored this bylined article on final FDA enforcement guidance stating that the agency will not require compliance with regulatory controls applicable to three kinds of Class I, premarket clearance-exempt health information technology products. The guidance “does not offer developers and manufacturers long-awaited direction regarding the regulatory requirements that may apply to clinical decision support software or electronic health records systems,” the authors wrote, but health IT developers “should welcome the FDA’s hands-off approach to regulation of the low-risk health data devices” contained in the guidance.