On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive policy statement outlining FDA’s plans to “modernize” the Agency’s medical device premarket notification (i.e., 510(k)) program.

​In the announcement, Drs. Gottlieb and Shuren explained FDA’s rationale for why the Agency would like to change the existing process to clear certain medical devices through the so-called 510(k) pathway.  The current 510(k) process has been in existence since the mid-1970s.  This recent 510(k) announcement is a follow-up from FDA’s April 2018 Medical Device Safety Action Plan (Safety Action Plan).

Background

The Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) were enacted in 1976.  The Medical Device Amendments created a risk-based classification system for all medical devices and established the regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k)).  In 1990, the Safe Medical Devices Act defined “substantial equivalence,” which is the standard for marketing a device through FDA’s 510(k) program.  Substantial equivalence means that the new device is at least as safe and effective as the predicate (i.e., the legally marketed device to which the new device is being compared).  A device is substantially equivalent if, in comparison to a predicate, it:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;

              or

• has the same intended use as the predicate; and
• has different technological characteristics and does not raise different questions of safety and effectiveness; and
• the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.

The 510(k) process is significantly less burdensome than the PMA process – most PMAs require clinical data whereas most 510(k)s do not – and this is one of the reasons the 510(k) process is popular among medical device firms, physician entrepreneurs, hospitals, and academic medical centers, with some estimating that approximately 80 percent of devices on the U.S. market have been developed and cleared pursuant to FDA’s 510(k) program.

Summary of the Proposal

There are several key take-aways from FDA’s statement that interested parties should monitor as the Agency moves to the next phase of this process:

• Public Disclosure of Use of Predicates More Than 10 Years Old: FDA believes that newer devices should be compared to the benefits and risks of more modern technology and it is considering making public on its website those 510(k)-cleared devices that demonstrated substantial equivalence to predicates that are more than 10 years old.   FDA’s stated goal is to drive sponsors to continually offer patients devices with the latest improvements and advances.  The Agency will be seeking public feedback on this aspect of the proposal.
• Potential Sunsetting of Older Predicates; Promotion of the Use of Modern Predicates: FDA is considering a sunset of certain older predicates and promotion of the use of more modern predicates.  This may require the enactment of new legislation.
• Alternative “Safety and Performance Based” 510(k) Pathway/Abbreviated 510(k) Program By a Different Name?: FDA’s announcement suggests that in early 2019 it 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.  The Agency believes this approach is the “future of the 510(k) program.”  It is not known what “objective safety and performance criteria” will be used to demonstrate substantial equivalence, and how, if at all, this pathway will substantively differ from FDA’s abbreviated 510(k) pathway, which relies on the use of guidance documents, special controls, and recognized standards.

Initial Industry Reaction to FDA’s Announcement

The President and CEO of the Advanced Medical Technology Association (AdvaMed) observed that the Agency’s “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.”  AdvaMed noted that “in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense.”

FDA’s potential sun setting of older predicates is the aspect of the proposal that could have the most significant impact on industry, physician entrepreneurs, hospitals, and academic medical centers.  If, for example, parties are no longer able to rely on certain predicates, they would no longer be able to market their devices unless they found a more recent predicate, or unless they obtained another clearance or approval.  This could produce gaps in the marketplace.

What Happens Next?

As the old adage goes, “the devil is in the details.”  While the announcement was long, many questions and details were not provided in the statement.

While FDA may need legislation enacted to achieve some of its goals, it is not yet clear whether Congress will be interested in moving forward with any legislation or the priorities it may consider.

FDA stated it will seek public comment on certain aspects of its proposal.  We will provide updates as details about those opportunities and about the Agency’s proposal become available.  The 510(k) process is integral to the medical device marketplace and any regulatory or legislative changes will likely be the subject of considerable debate.