Sara M Klock is Associate in Holland & Knight's Washington D.C. office

Jennifer M Nowak is Associate in Holland & Knight's Washington D.C. office

Ethan Jorgensen-Earp is Public Affairs Advisor in Holland & Knight's Washington D.C. office

On Nov. 26, 2018, the U.S. Food and Drug Administration (FDA) Commissioner and Director for the Center for Devices and Radiological Health (CDRH) announced FDA's plan to "modernize the FDA's 510(k) clearance pathway." The FDA calls its modernized approach the "Safety and Performance Based Pathway."

The FDA classifies devices into three classes — Class I, Class II and Class III — based on the level of control necessary to assure safety and effectiveness. A sponsor wishing to bring a medical device to market must first classify the device based on its intended use and indications for use, which are conveyed in product labeling and sponsor communications. Class II devices are "moderate risk" devices, which generally require sponsors to obtain "premarket clearance" by submitting a 510(k) application to the FDA demonstrating the proposed device is substantially equivalent to a predicate device.1 The FDA will find a device to be substantially equivalent if, in comparison to a predicate, it has the same intended use as the predicate, and meets the following requirements:

  1. has the same technological characteristics as the predicate, or
  2. has different technological characteristics, and
  3. does not raise different questions of safety and effectiveness, and
  4. the information submitted to the FDA demonstrates that the device is at least as safe and effective as the legally marketed device2

The FDA's data indicates that "nearly 20 percent of current 510(k)s are cleared based on a predicate that's more than 10 years old," and while that does not necessarily mean the predicate is unsafe, it does demonstrate that "some devices may not be continually improving, which is the hallmark of health technologies." The agency's goal is to push sponsors to stop or limit their reliance on predicates that are outdated and may lack modern performance characteristics, and rely instead on more modern predicates, which will allow the FDA to approach 510(k) submissions on a contemporary baseline that "looks to the future and ... can be updated as technologies advance," rather than relying on older technology as the precedent. The Safety and Performance Based Pathway, as the FDA explains, is aimed at creating greater market competition, while at the same time "is a direct and transparent approach to demonstrating the safety and effectiveness of low to moderate risk devices." Furthermore, this updated pathway would "provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well informed health care decisions," by encouraging sponsors to rely on modern objective safety and performance criteria to demonstrate substantial equivalence.

The FDA is using the 10-year look-back as a starting point, and it plans to seek public feedback on this timeframe and whether the agency should take other actions to advance the use of modern predicates. The FDA plans to publish a list of devices demonstrating substantial equivalence to older predicates against the wishes of the medical device industry. Furthermore, the FDA plans to develop policy to actively sunset older predicates and require the use of newer predicates. To do this, the FDA acknowledges it may need congressional approval or guidance.

As a result of its modernization efforts, the FDA notes that it believes more sponsors will obtain premarket clearance through the De Novo pathway, which is reserved for those low- to moderate-risk devices that do not have an appropriate predicate device. Although the FDA did not elaborate on its reasoning, this would be a likely result if the use of outdated predicate devices is limited. The FDA published a Notice of Proposed Rulemaking on Dec. 7, 2018, clarifying the De Novo classification process and criteria.

The FDA's announcement is another step in the agency's push to modernize and stay current on medical device technology to maintain the agency's "global gold standards for safety and effectiveness." We expect to see this movement continue as the FDA issues additional regulation and guidance related to these policies and other modernization efforts.

Footnotes

1 21 C.F.R. §807.92(a)(3)

2 21 U.S.C. §360c(i)(1)(A) 

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