On November 26, 2018, FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, announced the agency’s intent to modernize the medical device 510(k) clearance pathway. Since first adoption in 1976, the 510(k) process has facilitated and streamlined the approval of many medical devices based on predicates. With advances in technology, safety, and the capabilities of a new generation of medical devices, the FDA recognizes the need for change.

Put simply, the medical device landscape has shifted profoundly since the 510(k) process was first implemented over 40 years ago. Therefore, the FDA’s announcement shouldn’t come as a major surprise to many medical device and life sciences organizations. The FDA under Gottlieb has already taken a proactive approach to promoting innovation, collaboration, and efficiency. For example, in 2017, the FDA announced plans to support digital health initiatives and streamline regulation for mobile technologies. Many of 2018’s major medical device trends are also centered on actualizing opportunities like big data and analytics, artificial intelligence, and digitization.

Seeing a consistently large volume of entries, the FDA’s 510(k) program is the most common premarket review pathway for medical devices, so altering it projects to be a significant endeavor. For instance, in 2017, the Center for Devices and Radiological Health (CDRH) cleared “3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved.” Meanwhile, over the years, the FDA has also increased its expectations for the quality of content in its 510(k) submissions, resulting in the average size of submissions ballooning from 475 pages to 1,185 pages since 2009.

One step the FDA has taken to address the volume of submissions is through the Quality in 510(k) Review Program Pilot, launched on September 6th, 2018. The Quik Review Program supports the FDA’s goals in improving the logistics of submissions and standardizing on an electronic platform. The program uses the FDA’s eSubmitter software to encourage medical device manufacturers to take advantage of established templates that reflect the past 510(k) process, allowing submissions to be reviewed faster than through traditional pathways.

Both the Quik Review Program and the newly announced changes to the 510(k) pathway reflect the FDA’s goals to modernize its process while simultaneously raising the standards for performance and safety.

The FDA is Pushing Organizations to Innovate

Innovation can be incremental and gradual; it can also be rapid and disruptive. One of the reasons why the FDA has announced its intent to change the 510(k) process is because it is unclear whether the pathway is truly pushing organizations to pioneer solutions and innovate at an optimal rate. By design and according to protocol, manufacturers frequently rely on comparative testing against predicate devices to prove the new device is as effective. According to the FDA’s press release, “data show that nearly 20 percent of the current 510(k)s are cleared based on a predicate that’s more than 10 years old.” Just because a new product is based on an older one doesn’t mean it’s less productive or unsafe. However, because it is often more straightforward to design incrementally off of a known predicate device, there is a valid question as to whether new devices are incentivized sufficiently to continually improve in performance – a key consideration for health technologies.

The scenario is somewhat reminiscent of the iterative trend seen from Apple’s iPhone upgrades the past few years. Many consumers have become increasingly skeptical about new iPhone releases, because while the devices do offer new features, the situation begs the question: are the new products truly better than older versions? If organizations’ products are selling and there isn’t enough tangible pressure or competition to take risks and improve performance, organizations may take an expectedly calculated approach towards innovation.

In order to spur more innovation, the CDRH is considering publicizing on its website a list of cleared devices that “demonstrated substantial equivalence to older predicate devices.” The FDA wants the public to be aware of which technologies are based on predicates that are more than 10 years old, with the goal of driving sponsors to offer patients devices with the latest improvements and enhancements.

At the same time, while the FDA provides transparency into predicate devices, it is also prioritizing the marketing and exposure of truly novel devices. In some cases, consumers aren’t aware that new smart medical devices actually boast significantly enhanced interconnectivity, interoperability, and cybersecurity as compared to their predicates. For instance, BigFoot Biomedical has introduced two smart devices, an insulin pump and insulin pen, that incorporate AI-powered algorithms to increase the performance of delivery. Another device, the Smart Drill, provides real time feedback that helps surgeons select drilling depths and bone densities optimal for screw insertions.

The changes to the 510(k) program are meant to benefit and cater to increasingly complex medical technologies. While devices like imaging machines, drills, or monitors may resemble predicate devices, they often have significantly more advanced features, miniaturized components, or incorporate robotics and advanced materials. Because these types of devices are causing healthcare providers and patients to interact differently, the FDA has identified the need to transform their pathways to approval.

Prioritizing Safety Standards

Medical device safety has been an extremely hot topic as of late, as the industry has come under fire as a result of documentaries like “The Bleeding Edge”, which have aimed to expose the adverse effects of certain medical innovations. In the media and press, there have also been many instances of high profile medical devices underperforming and harming patients. Specific examples include metal-on-metal hip implants, vaginal mesh or treatments of pelvic organ prolapse, and automated external defibrillators. Many are concerned that device manufacturers are innovating at the expense of safety, and the notion that “new doesn’t mean better” is one the FDA is working to address.

Many of these devices do provide massive benefits for patients. However, due to their complex nature, they carry a higher level of risk such that they can no longer be brought to market via the traditional predicate-based 510(k) pathway. One of the ways the FDA has dealt with such devices in the past is through “up-classification,” which involves the re-assignment of a device to Class III and additional requirements for premarket approval before a device can remain on the market. The problem with up-classification is that it is extremely time and resource-intensive because it involves rulemaking on a case-by-case basis. Overall, the current process for approving devices introduces an inherent tradeoff between time and safety.

There needs to be discussion to breed action about how safety measures can be improved. One step that the FDA has already taken was the announcement of its Medical Device Safety Action Plan, through which it has outlined key safety actions:

• Establish a robust medical device patient safety net in the United States
• Explore regulatory options to streamline and modernize timely implementation of post-market mitigations
• Spur innovation towards safer medical devices
• Advance medical device cybersecurity
• Integrate CDRH pre-market and post-market offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety

Even though it has described its goals, the specific ways the FDA will enforce higher safety standards have yet to be fully solidified. Change will likely stem from a collaborative approach between the FDA and device manufacturers.

Medical Device Makers can Adapt and Shape New Processes

Similar to previous FDA announcements and pilot initiatives, this change to the 510(k) pathway is not meant as an obstacle or mandate to device manufacturers, it is really the introduction of an open dialogue between collaborators. As organizations review their regulatory strategies in the wake of this news, they will be forced to assess how they are currently incorporating predicates. In the past, it was common practice to use the most current predicates, ensure they aren’t under recall, and model new devices to meet and equivalate to those past standards. Now, organizations will need to think critically about how they are quantifying and qualifying both performance and safety with respect to modern expectations set forth by the FDA.

Developing adequate success criteria and testing metrics will be a significant challenge for the FDA and medical device manufacturers. It is likely organizations will reach out to partner with the FDA as soon as they can in order to get a leg up in understanding the newest approval processes and gain a clearer sense of the standards the FDA are promoting. Aligning on such standards will be a complex process. For example, how does one define acceptability or adequacy by “modern” standards? With so many different categories of devices, how can the FDA form consolidated device groupings to expedite processes? What types of quantitative metrics can be standardized across performance and safety testing? From a logistical standpoint, what’s the timeframe for enforcing and making these prospective guidelines official?

The Bottomline on 510(k)

Medical device manufacturers need to be aware of the most recent changes as they are developing. They also need to know that they can play an active role in shaping their own futures when it comes to navigating the changing medical technology landscape. In the modern medical device space, it is critical to understand what pathways are available for approval, as well as what pathways are continuing to evolve, in order to position oneself strategically. There are now different strategies to bring low-risk devices to market faster, and there will also be new pathways for bringing highly innovative products to market and gaining credibility in the eyes of consumers.

How can organizations assess their product pipelines to align with evolving regulations? How do device manufacturers structure themselves to generate solutions that are both high-performing and safe for consumers? What are the best ways to collaborate effectively with the FDA on new testing processes? In what ways can organizations use changing guidelines to shape their own strategies?

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Coauthor and contributions by Adam Kershner, Brandon Regnerus, Kevin Merchak, and Allie Gordon