FDA’s two recent announcements concerning the medical device industry are clear indications of the agency’s focus on risk reduction while encouraging innovation with increased oversight. These latest initiatives, the November 20, 2018 announcement on updates to the Medical Device Safety Action Plan post-market surveillance and the November 26, 2018 announcement of transformative new steps to modernize the 510(k) program, further agency initiatives to develop a more robust pre-market approval program for devices as well as build on a vision that was first announced in 2012 that looked to establish a “U.S. post-market surveillance that quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearances.” Both tasks are monumental, and both aim to improve safety and efficiency. Both are also important steps forward, which will have direct and lasting impact on the medical device industry including manufacturers, patients and their providers.
FDA’s 510(k) program is the most commonly used device premarket review pathway, with 3,173 devices being cleared through the 510(k) system in 2017 alone, which represents 82% of the total devices cleared or approved. While this is an impressive number, nearly 20% of those products, according to the FDA, were cleared based on a predicate device that is more than 10 years old. This concerning statistic hints at the unfortunate possibility of stifled innovation as, in an effort to expedite the pathway to market approvals, some devices may have based their application on an older predicate that may not utilize the updated technologies used today. FDA agrees and believes that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for newer advances in technology or demonstrate that they meet more modern safety and performance criteria.
In order to facilitate that, FDA is planning to take steps to “retire” outdated predicates, particularly those where safer or more effective technology has been developed (FDA has already retired devices where safety concerns warranted treating them as high-risk technologies). More controversially, FDA will be seeking public feedback on a plan to make available on its website those cleared devices on the market today that demonstrate substantial equivalence to older predicate devices, starting with predicates that are more than 10 years old.
To be clear, FDA is not saying that because a product is old it is unsafe, but it is saying that as advances in material science, digital health, 3-D printing and other technologies continue to evolve, eliminating older predicates is one way to foster that innovation.
Likewise, FDA’s regulatory approach must also modernize to safely and efficiently keep pace with these complex innovations that offer opportunities to improve healthcare. In addition, the agency must stay ahead of the new risks that sometimes accompany this progress including the challenges of interconnectedness, interoperability, increasing cybersecurity threats, and so on.
To that end, FDA is also focusing on improvements to the medical device post-market surveillance system, which currently relies on self-reporting of problems directly to the agency (and it can therefore be assumed, underreporting). The agency is moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information. Their goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices” will be achieved multi-collaborative effort called National Evaluation System for Health Technology (NEST).
NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.
The goals for NEST are being accomplished in a number of ways. For example, FDA established a unique device identification (UDI) system in which medical devices labels are marked with a unique code that can be used to track the device through its distribution and use in patients. Currently the UDI system contains more than 1.5 million device records. In addition, the use of real-world evidence (RWE) in pre- and post-market decision-making will include that UDI electronic data as well as other data to advance FDA’s efforts to support the development of more effective post-market surveillance tools.
Today, the FDA regulates more than 190,000 distinct devices which have evolved exponentially as technologies have improved, including miniaturization, portability and automation through advances in materials and production techniques that change the way healthcare providers and patients interact with them.
FDA’s latest efforts at improving safety controls while at the same time encouraging innovation spurs the industry to take new risks in development while keeping patient safety protocols in mind. Since 1976 device manufacturers have had the opportunity to pursue an expedited approval process, provided they could prove their new products were substantially equivalent to those that were grandfathered in when Congress established the 510(k) pathway. In some cases, this reliance on older predicates has actually made it more difficult for advanced technology to reach patients, as it is hard for an innovative product to bridge to an outdated technology reflected in a decades-old predicate.
In early 2019 FDA intends to finalize guidance establishing an alternative 510(k) pathway that will allow manufacturers of certain well-understood device types to rely on objective safety and performance criteria in order to demonstrate substantial equivalence. This new initiative to market is to be called the “Safety and Performance Based Pathway” to reflect its focus on advancing improved safety and performance of new products that will require a company to demonstrate that their novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles.
FDA anticipates as part of this 510(k) policy overhaul that more devices will use the De Novo pathway, which permits a robust evaluation of novel devices and allows FDA to establish special controls for devices of the same type. Streamlining FDA’s ability to implement new special controls to address safety concerns, as well as to up-classify a device type (such as moving from a Class I to II, or from Class II to III), where appropriate, would complement FDA’s NEST initiative by allowing more rapidly appropriate mitigations in response to an identified safety issue.
FDA will soon issue a proposed rule clarifying procedures and requirements for submissions of De Novo requests in order to establish a regulatory framework that sets clear standards, expectations and processes for De Novo classification as a way to continue to modernize the 510(k) process.
FDA also announced that President Trump’s budget for fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term.
It is a bizarre notion that safety and innovation are new criteria.