FDA Commissioner Scott Gottlieb today released a statement laying out the federal watchdog’s plans for improving medical device regulation, including plans to improve cybersecurity and monitor the total product life cycles of devices.
The announcement came as part of the FDA’s newly released “Medical Device Safety Action Plan”.
The plan focuses on five key areas, including improving medical device cybersecurity, integrating premarket and postmarket activities to monitor the total product lifecycle of products, establishing a medical device patient safety net in the US, exploring regulatory options to “streamline and modernize” implementation of postmarket mitigations and promoting safer medical device innovation, according to the FDA release.
Gottlieb said that the FDA will seek additional funding and authorities from Congress related to medical device cybersecurity, and will also look for approval to establish a new CyberMed Safety Analysis board.
The board would be a “public-private partnership to complement existing vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency,” Gottlieb said in the release.
In its move towards a “Total Product Life Cycle” approach to medical device management, the FDA said it will seek to guarantee that devices not only meet its “gold standard” for approval, but for the full life of the devices.
“As we move to the TPLC structure, we are exploring various new regulatory options to streamline timely implementation of postmarket mitigations as part of the Action Plan. For instance, we know that safe use of a device may require more than information in the labeling provided to physicians. To deliver reasonable assurance of safety and effectiveness for certain highly complex technologies, we may need to require additional training or user education. To do this efficiently under our existing authorities, we’ll consider issuing an umbrella regulation to identify these devices and mandate these requirements,” Gottlieb wrote.
The FDA will also consider “invoking restricted device authority” on high-risk devices to protect patients from harm, with Gottlieb specifying that the agency will consider the best way to impose those requirements while permitting safe use and protecting patient safety.
The agency will also consider further actions to improve innovation, including a similar program to its Breakthrough Device Program that would consider safer devices that don’t meet the Breakthrough Program criteria.
In support of safer device innovation, Gottlieb said the FDA is “exploring ways to permit more streamlined pathways for comparative safety claims as a way to spur competition on improving features related to a device’s safety profile.”
The plans include continued work on establishing the National Evaluation System for health Technology, which the agency will seek additional funding to advance during is fiscal year 2019.
Gottlieb said the FDA has also begun building out registries and establishing the Women’s Health Technologies Strategically Coordinated Registry Network which aims to provide “more complete evidence in clinical areas that are unique to women.”
Medtech industry group AdvaMed said it is ready to work with the FDA on its newly released action plan.
“The medical technology industry is committed to patient safety, and we take great pride in the strong safety record of the devices and diagnostics we produce that are doing so much to save and improve the lives of millions of patients worldwide. We agree with Commissioner Gottlieb’s remarks that ‘safety and innovation should go hand in hand.’ While we are still reviewing the details of FDA’s Medical Device Safety Action Plan, we stand ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices. Many of the provisions highlighted in the Safety Action Plan have enjoyed the strong support of industry for years, including development of a unique device identification system, efforts to protect against cybersecurity threats, and the use of real-world evidence to improve the understanding of device performance pre- and post-market. The current regulatory framework has served the American public well as it has continued to evolve to keep pace with innovation, but we believe every process can be improved and welcome discussion of any proposal that would positively impact patient safety and access,” AdvaMed CEO & prez Scott Whitaker said in a press release.
