The U.S. Food and Drug Administration (FDA) has released its “Digital Health Innovation Action Plan” to provide guidance on medical devices and software in the 21st Century Cures Act. The Center for Devices and Radiological Health (CDRH) was launched as a pilot precertification program for the development of digital health technology.
Over the last five years, FDA has implemented the Digital Health Program to develop polices relating to improving the benefits to digital health products. The program addressed measures on oversight on mobile medical applications for high-risk patients, outlined intentions to not focus on technology capable of receiving or storing medical device data, clarified expectations on cybersecurity and proposed new frameworks for health IT. With the new action plan, FDA aims to encourage further innovation in digital health by redefining polices and updating the tools need to provide clarify on these polices for the benefit of patients and providers.
“FDA recognizes that an efficient, risk-based approach to regulating digital health technology will foster innovation of digital health products,” stated the Action Plan announcement. “FDA’s traditional approach to moderate and higher risk hardware-based medical devices is not well suited for the faster iterative design, development, and type of validation used for software-based medical technologies. Traditional implementation of the premarket requirements may impede or delay patient access to critical evolutions of software technology, particularly those presenting a lower risk to patients.”
The action plan focuses on three main points:
- Issuing new guidance implementing legislation: The FDA will update current policies and issue new guidance on the 21st Century Cures Act to clarify software provisions including mobile medical apps, device data systems, imaging storing, communication and laboratory workflow. New draft guides stating clinical decision support software will no longer be under FDA jurisdiction. Issuing draft guides on products with both software functions and medical device oversight.
- Reimaging digital health product oversight: A new pilot program is being built for the development of regulating technology by looking at the developer and not the product.
- Growing expertise: The FDA will be employing new staff to the Digital Health Program within CDRH to expand the number of professionals with a background in software development to offer more in-depth counseling to developers with the hopes of being able to build higher quality digital health.
“FDA can help encourage digital health innovation by redesigning our policies and processes and modernizing our tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do,” stated the FDA in an announcement. “We have designed this Action Plan to set forth what we see as the next steps that we will take over the coming year.”