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.
Those aspects include whether it adequately addresses the relevant clinical evaluation methods and processes needed for SaMDs, whether other types of SaMDs than those outlined in the document should be addressed and whether the policy would produce unintended consequences for existing regulated devices.
“This is really huge, much bigger than many people might appreciate,” Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said in email to FierceHealthIT.
It would apply to a huge number of mobile apps, as well as stand-alone programs for PCs used in healthcare, Thompson said. Since clinical evaluation is typically the most expensive part of product development for them, the requirements will have a significant impact on the cost and time to market involved in developing them.
IMDRF, which has no authority under U.S. law, created this guidance, not FDA, he points out.
And while it calls for collecting real-world evidence for validation, it’s not clear about when real-world evidence might replace premarket clinical study.
While the FDA does not regulate the practice of medicine, it might be inappropriate for it to set validation requirements for software that merely informs clinical decision-making in cases where the doctor remains in control of those decisions, according to Thompson.
Health IT Now, in a statement, said that FDA reviewers, health IT developers and the public can benefit from ongoing efforts to clarify health IT regulation.
“This announcement also serves as a reminder that more needs to be done here in the U.S. to create regulatory certainty for developers and the public,” it said.