On November 26, 2018, FDA Commissioner Scott Gottlieb, M.D. and the Director of the Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D. announced FDA’s intention to take multiple actions in the near future to “modernize” the 510(k) program. As part of the announcement, the agency also released a “performance report” outlining the steps FDA has already taken to strengthen the 510(k) program. A number of proposals in the press release have drawn significant criticism from industry experts and have received wide coverage in the popular press. We offer a brief summary of these proposals, how they fit into broader FDA trends in the medical device space, as well as potential concerns that may arise as the agency seeks to implement the proposed changes.
FDA discussed four forthcoming proposals in its announcement:
1. In the coming months, FDA will propose a plan to “sunset” certain older predicates to promote the use of more modern predicates in 510(k) applications.
2. In the coming months, FDA will consider publishing on its website those cleared devices that demonstrated substantial equivalence to “older” predicate devices, discussing 10 years or older as a starting point.
3. In early 2019, FDA intends to finalize guidance establishing an alternative 510(k) pathway to allow manufacturers of certain well-understood device types to rely on “objective safety and performance criteria” to demonstrate substantial equivalence, rather than relying on a specific predicate device.
4. In the coming weeks, FDA will issue a proposed rule clarifying procedures and requirements for submissions of de novo requests in anticipation of greater reliance on that pathway as older predicates become unavailable to 510(k) applicants.
These proposals reflect the agency’s long-term efforts to balance the concerns of multiple stakeholders to both improve patient safety and streamline the clearance process for the device industry to spur innovation. These are not new concerns; as far back as 1998, FDA was experimenting with alternative 510(k) clearance pathways, creating both the Special and Abbreviated 510(k) pathways through guidance. However, there continued to be calls for changes to the 510(k) process. For example, the Institute of Medicine published a 2011 report in which it claimed that the statutory requirement of substantial equivalence to a predicate device did not adequately assure safety and efficacy, calling on Congress to completely change the 510(k) framework through new legislation. Both industry and FDA opposed the IOM’s recommendation. While there have been relatively few recent legislative changes to the medical device approval process, FDA has more recently experimented with ways to modernize. It is, for example, developing a Pre-certification Pilot Program for software that functions as a medical device and attempting to expand the use of Real-World Evidence to support its regulatory decision-making. In addition, a slew of recent journalistic endeavors likely contributed to the timing or strength of FDA’s recently announced proposals. The international consortium of investigative journalists just published several articles highlighting medical device safety concerns, while Netflix recently produced a documentary, The Bleeding Edge in the same vein.
FDA’s new proposals have garnered significant attention and pushback from the medical device industry, at least in their particulars (or lack thereof). Polsinelli has identified a number of issues with the proposals, including:
- FDA has not identified a regulatory process or mechanism by which it will sunset older predicate devices.
- FDA has clarified in subsequent statements that they did not intend for 10 years to be the settled upon or only criteria for deciding which predicates will be sunset or which medical devices will be publicly published for relying upon such predicates. Nonetheless, it should be noted that if FDA focuses exclusively on the age of a predicate, it would prove a poor proxy for safety concerns or identifying truly obsolete technology.
- FDA may not have the legal authority to sunset older predicates, or otherwise set limits on the age of a predicate that may be relied upon in a 510(k) application. Both “substantial equivalence” and “predicate device” are statutory terms without time limits that will need to be accommodated in any framework.
- Publishing all medical devices that rely upon “old” predicates will unnecessarily stigmatize those products and create an unsubstantiated association that they are unsafe or ineffective.
- FDA has not specified how it will treat cleared devices that rely upon multiple predicates, where some, but not all, predicates are “old.”
- FDA’s new alternative 510(k) pathway based on safety and performance standards was not clearly distinguished from the existing abbreviated 510(k) pathway, which itself has proven idiosyncratic and flawed over the years.
- FDA will need to maintain and update performance standards rapidly and continually in order to fully supplant the use of predicates, as the agency expressed is its ultimate long-term goal. This may prove far more challenging than the agency is willing to admit for certain innovative medical device categories.
Ultimately, many of these issues and concerns will depend upon the precise details of the forthcoming FDA proposals and responses from Capitol Hill. As noted, we can expect to see updates from the agency over the next few months. We are monitoring these developments and will be counseling our clients on the full range of issues raised by the agency and undoubtedly the 116th Congress.