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Newer medical devices can improve patient safety and performance, but they come with unique challenges.
The U.S. Food and Drug Administration (FDA) has announced plans to modernize its 510(k) program to advance the review of the safety and effectiveness of medical devices, while encouraging innovation and enhancing cybersecurity, according to a statement from senior officials.
The biggest proposed change is meant to drive innovators toward more modern predicate devices, which are existing low- and moderate-risk medical devices that may help fast-track FDA clearance for similar tech. Under the new proposal, the FDA would publicly spotlight medical devices that gained approval on the back of predicates that are at least 10 years old.
“The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety,” FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, said in the joint statement.
Data show that 20 percent of current 510(k) clearances are based on a predicate that is more than 10 years old. This does not deem the product unsafe, but it does mean that some devices may not be continually improving, which the FDA said is the hallmark of health technology.
The FDA said newer devices should be compared to the benefits and risks of more modern technology. The FDA will also retire outdated predicates, especially where safer or more effective technologies have emerged.
“Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances,” Gottlieb and Shuren said in the statement.
They said that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device. Modern predicates could also promote greater competition to adopt new features that improve safety and performance and help ensure newer devices with modern technology can improve patient care and outcomes.
With advances in material science, digital health, 3D printing and other technologies continuing to drive innovation in medical devices, the FDA said it’s critical to evolve the approach. The devices being reviewed under the 510(k) pathway are increasingly complex and new devices are more often interconnected and interoperable, which increases cybersecurity threats.
The new technology that we are seeing holds tremendous public health promise for patients, but with the complexities of said technology comes a more challenging review of a device’s safety and effectiveness.
The FDA wants to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance.
The FDA believes that it is time to modernize the framework, which was initially adopted in 1976, when Congress first established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years. Today, the FDA regulates more than 190,000 distinct devices.
“We believe firmly in the merits of the 510(k) process,” Gottlieb and Shurenthe release said. “But we also believe the framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”
The new approach would be called the Safety and Performance Based Pathway. The regulator is seeking public feedback on the proposal.
Similar recent innovation policies from the FDA include building a national patient safety net, charting a premarket review path for breakthrough products and enabling the use of rigorous, objective criteria to serve as a predicate for future clearances. The FDA has also promoted new ways to safely advance medical devices to diagnose cancer, repair damaged hearts and manage diabetes, the agency said.
“Many of these efforts aim at adopting a more modern process that allows the FDA to incorporate new technologies that improve the safety and performance of medical new predicates to serve as benchmarks for future clearances,” Gottlieb and Shuren said.
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