The US Food and Drug Administration (FDA) is planning to overhaul the framework for evaluating the safety and effectiveness of medical devices, the 510(k) clearance pathway, which was passed as a law forty-two years ago by the Congress.
Image: FDA’s Center for Devices and Radiological Health building. Photo: Courtesy of The U.S. Food and Drug Administration.
The US regulator announced changes to modernize the 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews.
The changes are being pursued to keep pace with the increasing complexity of rapidly evolving technology.
As per the federal agency, new medical devices that come to the market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.
The agency stated that new devices must be evaluated against the advances in technology that can improve patient safety and performance. In making these reviews, it wants to rely on modern safety and performance criteria.
At the same time, the FDA will take actions that will allow it to retire outdated predicates, especially in cases where safety issues have emerged in the past.
With the 510(k) process, FDA can recognize that medical devices exist across a continuum of complexity and risk and that the scope of premarket review should reflect this risk continuum.
The agency said that ‘a one-size-fits-all’ regulatory approach would not optimize public health outcomes, would not be efficient in advancing beneficial new technologies to patients and would not allow it to effectively prioritize its scientific resources.
When the Congress created the 510(k) process, it was a paradigm shift for FDA, which was into the regulation of drugs. The distinct challenge of regulating broad, diverse group of medical products was recognized. Today, the FDA regulates more than 190,000 distinct devices.
As part of the Safety Action Plan, the federal agency will modernize the 510(k) program. This is a pathway used for clearance of low to moderate risk advices that substantially equivalent to a device already on the market – otherwise known as a predicate devices.
Last year, the agency claims to have cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved.
Newer devices should be compared to the benefits and risks of more modern technology. To advance these goals, the Center for Devices and Radiological Health (CDRH) is considered to make cleared devices public on its website, that showed substantial equivalence to older predicate devices.
The agency will also consider focusing on predicates that are more than 10 years old as a starting point, so that public is aware of these technologies.
As per FDA, manufacturers generally rely on comparative testing against predicate devices to show that a new device is as safe and effective as the predicate device. Older predicates may not closely reflect modern technology embedded in new devices, or the current understanding of device benefits and risks.
Nearly 20% of the present 510(k) approvals are cleared based on predicates that are more than 10 years old. It does not mean that the products are unsafe, but such devices may not be continually improving, which is the hallmark of health technologies.