FDA’s Sort-of-Final 510(k) Proposal

The Food and Drug Administration (FDA) on January 22 posted a new, more-or-less final plan to change the 510(k) medical device process, pending public comments.

The plan follows the outline in a November 26, 2018 joint statement from FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren. The basics are:

1. Expanding and renaming the “abbreviated” 510(k) program

Under this little-used program, a manufacturer can demonstrate substantial equivalence through performance criteria instead of comparing a device to a predicate device. FDA issued a draft version of its proposal to expand this alternative April 12, 2018, calling it the “Safety and Performance Based Pathway.” An updated version of the April 12 proposal was posted January 22, 2019 with an issuance date in the document of February 1, 2019.

2. Moving the device industry away from older predicates for traditional 510(k)s

In a separate action, FDA is asking whether it should pressure device manufacturers into basing 510(k) applications on predicate devices newer than 10 years old.

A first step in this plan would be to post on the FDA website a list of 510(k)-cleared devices which used devices older than 10 years as their predicates for demonstrating substantial equivalence.

“The Agency is considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. FDA’s goal in focusing on older predicates is to encourage sponsors to continually offer patients devices with the latest improvements and advances.”

In addition, FDA is asking for input on “other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices.”

Also, the agency is asking whether it should request authority from Congress to take actions such as completely banning some older devices as predicates.

The plan has sharp critics on both sides of the debate

FDA regulatory attorney Mark Duval warned clients in a recent, detailed memo to get ready for “increased product complexity and risk aversion” from the FDA. Shuren and his team “disdain” the 510(k) clearance program and are intent on sweeping changes, our legal reporter Walter Eisner reports in his January 9 Orthopedics This Week story, “FDA Forecast and Analysis for 2019.”

However, in a January 4 article titled, “The FDA is still letting doctors implant untested devices into our bodies,” Washington Post reporters Jeanne Lenzer and Shannon Brownlee, wrote disdainfully that “According to the FDA, the ‘most impactful’ change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years.”

“Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears,” the reporters wrote.

Actually, that report didn’t fall on deaf ears at all, Mark Duval said in his memo to his clients. “That attempt,” led by Shuren, “was met with a huge industry counter- movement.”

In a January 8 commentary, “Does the 510(k) Program Need Predicate Modernization?”, in the FDA Law Blog of the law firm Hyman Phelps & McNamara, author Jeffrey K. Shapiro looked at 400 clearances chosen at random from 2017 and 2018. He found that “out of 53 clearances with predicates older than 10 years, 27 clearances also cited at least one predicate under 10 years old. These ‘mixed bag’ clearances amount to 14% out of total clearances. The other 26 clearances relying exclusively on predicates over 10 years were 13% of total clearances.”

“It is a judgment call whether the “mixed bag” clearances should be considered a problem …” But if a 510(k) submission reaches back to include a predicate that is older than 10 years, while at the same time citing a predicate that is under 10 years, can one say a priori that insufficient innovation has taken place? It would seem that one would need to examine the clearances in detail to reach an informed judgment.”

The same is true, he said, for devices cleared only with predicates more than 10 years old. He cites a penile implant cleared based on “four predicates, two dating to 2002 and two dating to 2004 … In this case, the long marketing history due to the age of the predicates potentially provides greater assurance of safety than would have been the case with a novel material.”

We saw a similar phenomenon in a recent spine device recall we’re researching for a possible news story. The 510(k) for this device cites 198 predicates. Of those 198, all but 13 were themselves 510(k)s based on an original 13 pre-market applications – nine in 2004, three in 2005, and one in 2006, so the newest original PMA is 13 years old.

The reason for this recall is solely related to that which is brand new in the device – the 3D printing technology used to create it.

The Safety and Performance-Based Pathway: Fine Print to Come

FDA’s handling of this expansion of the “abbreviated” program is a bit of a puzzle. The updated January 22 document says comments can be submitted at any time by visiting https://www.regulations.gov/ and entering docket number FDA-2018-D-1387.

Go there, and the resulting page says the comment period closed last July 11. However, the docket apparently still does allow comments.

This 14-page document says, “FDA plans to provide information about the types of devices to which the performance criteria would apply in the guidance establishing the performance criteria.”

It also says this list of types of devices will be “accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended in the guidances where feasible, and any other relevant information. These guidance documents may reference consensus standards, or portions of consensus standards, recognized by FDA under section 514 of the FD&C Act, as well as special controls established for that device type and relevant FDA guidance.”

In other words, you’re being asked to comment on a pig in a poke regarding which device types might fall under this approach and how they’re to be tested.

Also, “abbreviated” is in quotes because, on the average, this approach takes more time to get a clearance than the traditional 510(k) process. See our related story on average approval and clearance times.