- FDA Commissioner Scott Gottlieb on Tuesday released an agenda aimed at enhancing medical device safety and innovation in the U.S.
- The five-pronged Medical Device Safety Action Plan is built around a total product life cycle approach that calls for integrating the Center for Devices and Radiological Health’s (CDRH) premarket and postmarket offices across functions.
- The plan comes as first-in-kind products are reaching the market. Last year, the FDA approved the first automated insulin delivery device for type 1 diabetes and a blood test to evaluate traumatic brain injury.
In recent years, the FDA has taken steps to increase access to novel medical technologies, including allowing use of real-world evidence to support device refinements and establishing a regulatory framework for digital health devices. Safety enhancements are a major part of that thrust, Gottlieb said.
In addition to reorganizing the premarket and postmarket offices, the plan calls for:
- Creating a robust medical device patient safety net;
- Exploring regulatory options to streamline and modernize postmarket risk mitigations;
- Incentivizing innovation of safer devices; and
- Advancing medical device cybersecurity.
As part of the new safety plan, the FDA may require additional training or user education for some highly complex technologies identified under an umbrella regulation. The agency is also considering restricting access to some highest-risk devices to minimize harm.
The FDA also plans to develop scientific toolkits to help product design teams meet federal safety standards. In addition, the agency wants to spur competition with streamlined pathways for comparative safety claims.
“We want to take new steps to encourage manufacturers to make even modest iterative changes to their devices, if these new advances and adaptations will lead to a reduction in risk to patients,” Gottlieb said in announcing the safety plan.
Other initiatives include improving the quantity and quality of real-world evidence generated for devices intended for women and enhancing cybersecurity. To that end, the agency is asking Congress for authority and funding to develop a public-private CyberMed Safety Analysis Board to complement current cybersecurity vulnerability and response efforts.
AdvaMed said it is still reviewing the action plan, but pointed to industry support for a number of the provisions, including advancing cybersecurity and use of real-world evidence to support device performance.