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The US Food and Drug Administration (FDA) on Tuesday released a medical device safety action plan with five key focus areas related to improving the quality of real-world evidence, improving postmarket surveillance, spurring innovation around safer devices, advancing cybersecurity initiatives and reorganizing the Center for Devices and Radiological Health (CDRH).
While noting the promise of CDRH’s National Evaluation System for Health Technology (NEST) in offering an additional source of information for device manufacturers to assess the safety and effectiveness of their devices, FDA said it intends to explore whether it can impose special controls when warranted to address new or increased risks.
Currently, FDA can require companies to implement what it calls “mitigations (e.g., labeling, user training, device features)” through additional special controls, but such controls require a rulemaking, which the agency said can be challenging when issues need to be addressed quickly.
“As a result, FDA often works with individual manufacturers to voluntarily implement mitigations, an approach that is not always effective,” the action plan says. “Accordingly, FDA intends to consider other actions that can be taken. Specifically, FDA will: Explore whether, under current statutory authorities, FDA can impose special controls, when warranted to address new or increased known risks, more quickly through the issuance of an umbrella regulation; and if not, explore what additional actions might be taken, including considering potential new authorities.”
Following the release of draft guidance last week on establishing a voluntary, more modern 510(k) pathway for demonstrating safety and effectiveness for certain moderate risk devices, the agency also said it will launch a pilot program “intended to establish organizational performance metrics and device quality metrics that can be tracked in a ‘dashboard’-like format to facilitate continuous monitoring and, accordingly, improved visibility to potential manufacturing, product quality, or patient safety issues. The pilot will evaluate the effectiveness and scalability of the model with the goal of standing up a voluntary third-party appraisal program in 2019.”
On the cybersecurity front, FDA said it plans will include consideration of “potential new premarket authorities to require firms, on the front end, to: (i) build capability to update and patch device security into a product’s design and to provide appropriate data regarding this capability to FDA as part of the device’s premarket submission; and, (ii) develop a ‘Software Bill of Materials’ that must be provided to FDA as part of a premarket submission and made available to medical device customers and users, so that they can better manage their networked assets and be aware of which devices in their inventory or use may be subject to vulnerabilities.”
And as previously announced last September, CDRH is still pushing to reorganize its structure to better track devices’ total product lifecycles (TPLC). The reorganization will include a move to one large office comprised of seven smaller device-specific offices that would be responsible for premarket review, postmarket surveillance, manufacturing and device quality, and enforcement.
“The design also would include a new office that would be dedicated to clinical evidence and analysis, under which teams would be focused on clinical evidence policy, evidence synthesis and analysis, biostatistics, bioresearch compliance, and collaboration with and outreach to clinical researchers outside of FDA," the plan says. "The new office’s objectives would include advancing the generation of more informative data across the TPLC about the benefits and risks of new devices that would help inform regulatory decisions of CDRH staff throughout the TPLC organization."
FDA Commissioner Scott Gottlieb said in a statement: “These new steps will be all the more effective because of the extensive work we’ve done over the past years to modernize our data gathering infrastructure around device safety – such as our Unique Device Identification System (UDI) and use of real world evidence (RWE).”
Medical Device Safety Action Plan