FDA Eyes Changes to 510(k) Program

FDA wants to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews.

The agency said it is pursuing changes to the program in an effort to help keep pace with the increasing complexities of evolving medical technology. It's important to note that the Center for Devices and Radiological Health (CDRH) cleared 3,173 medical devices through the 510(k) pathway in 2017, representing 82% of the total devices cleared or approved by FDA.

"The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging," said FDA Commissioner Scott Gottlieb, MD and CDRH Director Jeff Shuren, MD, in an agency statement issued Monday. "The framework we propose is aimed at efficiently advancing beneficial technology to patients while solidifying FDA’s gold standard for safety."

The news comes at a time when the medical device industry and regulatory bodies like FDA are facing increased scrutiny from the public in light of mass media coverage concerning the safety of some types of medical devices. Most recently, an international consortium of investigative journalists published a harrowing report pointing to more than 1.7 million device-related patient injuries and nearly 83,000 deaths reported to FDA over the past decade.

The 510(k) clearance pathway, in particular, came under fire in July after Netflix released The Bleeding Edge documentary, which offers a poignant look at specific medical device categories that have adversely impacted patients. MD+DI interviewed the filmmakers and published several pieces on the documentary, including a slideshow of the film's most powerful moments, an op-ed from a biomedical engineering expert, and a story based on reader feedback about the film.

Before that, a 60 Minutes segment that aired in May brought renewed attention to transvaginal mesh devices with a particularly harsh focus on Boston Scientific (the company denied any wrongdoing and shared its side of the story with MD+DI soon after the 60 Minutes report aired).

So it's not surprising that FDA is taking a hard look at the most commonly used regulatory pathway for getting medical devices to the U.S. market. Nor is it surprising that one of medtech's largest trade associations has something to say about the agency's 510(k) modernization plan.

"While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved. and we stand ready to work with FDA and all stakeholders toward the shared goal of enhancing the current review paradigm," said Scott Whitaker, president and CEO of AdvaMed. "We look forward to learning more about the agency's plans to implement an alternative 510(k) pathway and to encourage the use of more recent predicates."

Out with the Old?

The use of older predicate devices as a means of demonstrating the safety of new medical devices has been one of the key pain points of the 510(k) process. The Bleeding Edge documentary highlighted this aspect of the regulatory pathway by pointing out that in some cases new devices have been cleared for marketing based on older predicate devices that have been recalled due to safety concerns.

According to FDA, nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That's not to say the products are unsafe, the agency said, but it does mean that some devices may not be continually improving. FDA said it will pursue additional actions that will allow the agency to retire outdated predicates, especially in cases where safer or more effective technology has emerged.

"We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria," Gottlieb and Shuren said in the agency's statement.

Modernizing the 510(k) pathway falls under the five-pronged Medical Device Safety Action Plan that FDA first revealed to the public in April, followed by a public comment period that ended Aug. 17. AdvaMed and Johnson & Johnson were among the industry leaders that raised concerns with some of the specifics of the plan, as did the American Association of Neurological Surgeons and Congress of Neurological Surgeons. Read about those concerns here.

FDA said it took those public comments into consideration, along with the agency's own data, in the formation of the plan to modernize the 510(k) pathway. The agency said it determined that the most impactful way to promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices (within the past 10 years) or objective performance criteria when they seek to bring new devices to patients.

The agency said it is considering posting a list of predicates that are more than 10 years old on its website to make the public aware of those technologies and to encourage the device industry to base new device submissions on more recent predicates. FDA said it will first seek public feedback on whether the agency should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old.

"To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe 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, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward more modern performance standards," said Gottlieb and Shuren.

This focus on older predicates seems to raise a concern for AdvaMed. In some cases there are legitimate reasons for using older predicates, Whitaker said, and for some devices, the technology has not changed much so using those older predicates still makes sense.

"The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices," Whitaker said.

One argument that FDA makes for modernizing the 510(k) program is that newer devices are more often interconnected and interoperable, increasing cybersecurity threats. As MD+DI has previously reported, cybersecurity is a major problem in the industry and one that manufacturers need to take seriously. For those who don't believe cybersecurity is important in the medical device industry, just ask Redwood City, CA-based Guardant Health.

Guardant recently acknowledged in an SEC filing that the company experienced a security incident in July involving a phishing attack in which a hacker obtained access to an employee email account, compromising private information from about 1,100 people. The information accessed primarily included patients’ names, contact information, birth dates, medical diagnosis codes, and, in a very limited number of cases, Social Security numbers.

FDA also noted that miniaturization of device components has allowed devices to become smaller and more portable. Devices more frequently use automation and robotics, and advanced materials, changing the way healthcare providers and patients interact with them, the agency said.

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.

"Rather than looking to the past as a baseline for safety and effectiveness – and rely on predicate devices that are sometimes decades old as our point of comparison – our premarket review would be based on a contemporary baseline that looks to the future and a baseline that can be updated as technologies advance," said Gottlieb and Shuren. "Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate."

The agency also plans to rename this new approach the "Safety and Performance-Based Pathway." Other proposed changes are intended to promote greater transparency and post-market surveillance of newly cleared devices.