New Regulatory Paradigm Needed for Device Software: FDA

FDA says a recent pilot program on software as a medical device has shown that a new regulatory paradigm is needed to regulate such devices, but this would require a legislative change. Based on the observations from the pilot, FDA determined that the approach described in the pilot’s “working model is not practical to implement under our current statutory and regulatory authorities,” according to a CDRH executive summary.

“Ultimately, the approach to regulating novel, swiftly-evolving medical device software must foster, not inhibit, innovation, while continuing to provide reasonable assurance of safety and effectiveness,” the Center says. “These aspects are not mutually exclusive. A flexible, risk-based approach to regulation could allow FDA to tailor regulatory requirements more efficiently for devices based on the latest science, the benefits and risks posed by devices, their real-world performance, and their contribution to promoting health equity. It could leverage the capabilities of evolving medical device software so that health care providers, patients, and users can benefit from advancement and innovation, and so that risk for such devices can be reduced through swift software and cybersecurity updates throughout the TPLC [total product life cycle], when needed. New legislative authority establishing such an approach could be supplemental to, and not replace, the established regulatory pathways.”

CDRH says the pilot also “reinforced that a systems-based approach that leverages structured objective data can support a learning regulatory system that benefits from data-driven insights to provide efficient and consistent regulatory decisions. Such a system could better enable least burdensome paradigms that provide a reasonable assurance of safety and effectiveness for medical device software.”

The Center says that ideally the new regulatory paradigm should have:

• The ability to assess an organization’s ability to deliver devices with a commitment to a culture of quality and organizational excellence.
• ongoing visibility into key performance indicators, real-world performance metrics, and other data to enable timely and targeted actions to resolve issues, prevent adverse events, and increase regulatory compliance.
• Regulatory decision support tools that communicate FDA regulatory policies, which support frameworks for transparent organizational appraisals and communication of device performance by manufacturers.

Now that the pilot is over, CDRH says it will continue to “develop policies and tools within current authorities to improve the efficiency and effectiveness of regulatory oversight, including through collaborative engagement with the public, such as the Medical Device Innovation Consortium.”