Updated November 30, 2018

The US Food and Drug Administration (FDA) has announced it will be modernizing its 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews, and concentrate on more recent “predicates” (existing devices and technology) in its decision-making process. In a lengthy statement, the Agency said it is pursuing several changes to help keep pace with the increasing complexity of rapidly evolving technology with a new framework “aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.”

In particular, the Agency says it will rename its program the “Safety and Performance Based Pathway” to make sure that new medical devices coming to market under the 510(k) pathway meet modern safety and performance criteria, while it will also pursue additional actions that allow the retirement of outdated predicates—especially in areas where safer or more effective technology emerge, thus moving away from a “one-size-fits-all” approach. The FDA stated:

“To keep pace with these developments and advance these goals, in early 2019, FDA intends to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products. Our goal in finalizing this pathway that we discussed in our Medical Device Safety Action Plan is to expand its use broadly across the 510(k) program and make it the primary pathway for devices eligible for 510(k) review.”

The Agency has been considering revisions to the 510(k) process for almost a decade. 510(k) submissions are required for medical devices marketed in the United States to demonstrate that they are safe and effective or “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). Hearing aids, bone-conduction devices, and hearing-related implants qualify as Class I, II, and III medical devices, but were not specifically mentioned in the FDA’s press statement. It should also be noted that one of the recommendations made by the four major professional hearing-related organizations in a recent consensus statement, and later endorsed by the Hearing Industries Association (HIA), was that all future OTC hearing manufacturers be required to obtain an initial 510(k) clearance prior to marketing their product.

The announcement follows a well-publicized report detailing thousands of injuries from medical devices, including surgical mesh, hip protheses, spinal stimulators, insulin pumps, and defibrillators. The report came from the International Consortium of Investigative Journalists (ICIJ)and more than 50 other media partners around the world which collected and analyzed millions of medical records, recall notices, and other product safety warnings, in addition to interviewing doctors, patients, researchers, and company whistleblowers:

The ICIJ report places the Agency on the defensive. The FDA under Commissioner Scott Gottlieb, MD, has been adopting new industry-friendly measures that allow devices to come to market more quickly, while also increasing its post-market surveillance of products. It has been appealing to Congress for an extra $400 million funding for its proposed Center of Excellence for Digital Health and additional attention to the National Evaluation System for health Technology (NEST).

In its press statement, FDA points out that it regulates more than 190,000 distinct devices. The FDA’s Center for Devices and Radiological Health (CDRH) uses a risk-based paradigm to promote safety and effectiveness, and is now striving for a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances. These include the use of real-world evidence in regulatory decision-making, the De-Novo pathway for low to moderate risk novel devices, and to chart a premarket review path for breakthrough products. The De Novo pathway has been notably used recently for clearance of the Bose Hearing Aid, harkening a new class of self-fitting devices, as well as the Med-El ADHEAR Adhesive Adaptor System, a non-surgical bone conduction hearing technology.

In April, FDA issued its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which recognizes opportunities to continue to enhance programs to help improve device safety. As part of the Safety Action Plan, the Agency committed to strengthen and modernize the 510(k) program used for clearance of low- to moderate-risk devices that are substantially equivalent to existing devices on the market–also known as a “predicate device.”

With the 510(k) revisions, FDA believes that newer devices should be compared to the benefits and risks of more modern technology and more recent predicates. To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices, and considering focusing on predicates more than 10 years old as a starting point, so that the public is aware of those technologies. FDA reports its goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.

FDA will seek public feedback on whether it should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform our point of reference, and whether there are other actions it should take to promote the use of more modern predicates: “This market-based approach will promote the right kind of innovation for patients. Innovation that reflects the most modern principles. Among other steps, we’re developing proposals to potentially sunset certain older predicates and promote the use of more modern predicates. We’ll consider whether this approach should become a requirement in the future. To achieve some of these public health goals, we may need to seek additional guidance from Congress.”

It also cited the increasing complexity of the devices reviewed under through the 510(k) program. Medical devices are increasingly interconnected and interoperable, increasing cybersecurity threats, miniaturization of components allows for greater portability, and the devices frequently use automation, robotics, and advanced materials, changing the way healthcare providers and patients interact with them.

Additionally, FDA is posting a performance report that highlights some of the key achievements of the past decade, including the measures taken to increase the predictability and transparency of the 510(k) review process. These efforts include the more than 50 final guidance documents on important medical device policy issues issued since 2009.

“We’re seizing the chance to make a generational change in the framework for 510(k) reviews–one that advances its best features while making sure it keeps pace with modern innovation,” states the Agency. “In the coming weeks, we’ll provide additional updates on the status of our Medical Device Safety Action Plan and describe further steps we’re taking to promote patient safety. We’re proud of the work CDRH staff is doing to make sure that the devices we regulate are safe. We’ll continue to take new actions to strengthen the device program for the years to come.”

Source: HR and FDA