Continuing on the 510(k) Pathway or Finding a Different Route?

In my last Editor’s Letter, one of my “holiday wish list” items for 2019 was an improved industry image. To the general public, that includes the FDA and its oversight and regulations tied to medical devices. As such, efforts to enhance and update processes associated with the agency help with the overall impression of our industry and the work being done to improve on deficiencies.

Little did I know that so soon after writing the letter, the U.S. Food and Drug Administration (FDA) would get a jumpstart on fulfilling my wish list. In late November, the agency announced plans to modernize the 510(k) clearance pathway. FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, said in a joint statement, “We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.”

While I’m sure the first sentence of that excerpt from the statement is reassuring to some [i.e., they aren’t eliminating the 510(k) pathway], others will approach any changes to the regulatory system in place with trepidation. Completely understandable— the 510(k) has become the default standard regulatory pathway for the overwhelming majority of medical devices cleared or approved for sale in the U.S. marketplace (82 percent of all devices in 2017). So any modifications to that will undoubtedly touch virtually every medical device manufacturer.

One of the most prominent criticisms of the current 510(k) pathway is the reliance on predicate devices. More specifically, the concern is that the predicate device can be quite old. In fact, according to the statement, 20 percent of current 510(k) submissions rely on a predicate device that is over 10 years old. While that predicate device can still be deemed a safe and an effective solution being used for a therapeutic or diagnostic purpose today, it raises the question of whether a type of “expiration date” should be put on the predicate device in a regulatory submission.

In a response to the 510(k) Modernization effort announcement, AdvaMed’s president and CEO Scott Whitaker specifically commented on the concern with a predicate device’s age. “FDA acknowledges that its concern with older predicates only applies to a minority of devices and that those devices have no demonstrated safety concerns. It is our hope that through the regulatory review, the agency will recognize 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. 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.”

While this debate will undoubtedly be ongoing as stakeholders work with the FDA to improve upon any change to the 510(k) pathway, device manufacturers may find other routes through the regulatory system beneficial. One such option would be to take a device with a predicate already on the market and instead gain regulatory approval through a PMA submission. While a more expensive process, if a device can demonstrate clear advantages over the aforementioned predicate, it could be in the company’s best financial interests to take the PMA route. And we have the move toward value-based healthcare to thank for that.

In the column “A Primer for Manufacturers Adjusting to Value-Based Healthcare” on page 34, Vicki Anastasi of ICON mentions the advantages a device manufacturer can realize by choosing the PMA pathway over the 510(k). She states, “…from the provider’s perspective, claiming a device is equivalent to an older device means its worth is no more than the older device. So, for truly innovative devices, manufacturers must consider the worth of investing in a PMA program that gathers detailed clinical evidence and cost impact information, and at the same time, give the innovative device an edge once it is available on the market. Therefore, clinical and economic data are essential to developing a value-based case for higher payment.”

So while the 510(k) may still be the pathway-of-choice for a manufacturer’s “me too” product, a PMA could prove to be a better option for financial success. Although, in a value-based healthcare system, will a “me too” product be as successful a development strategy as it’s been in the past? And if not, will we see a decrease in 510(k) submissions due to companies seeking the best reimbursement opportunity? That answer remains to be seen. 

Sean Fenske, Editor-in-Chief
[email protected]