FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

  • December 06, 2018

“We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in November.  “Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” they said.


A more appropriate benchmark for firms to make comparisons to predicate devices when preparing 510(k) submissions would be to focus on predicates that more recently obtained FDA clearance, the Agency said.  The goal is to make the expanded Abbreviated 510(k) program the main pathway for devices subject to 510(k), as proposed in draft guidance issued in April and set to be finalized in early 2019.  The plan is to name the new approach for certain well-understood devices the “Safety and Performance Based Pathway.”

“To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices,” Gottlieb and Shuren said.  This is intended to promote the use of more recent predicates.

FDA acknowledged further Congressional support may be required to achieve the proposed modernizations, citing a time-consuming and inefficient process for up-classifying devices into Class III in response to safety concerns through implementation of new special controls.  It is also working on proposals to sunset certain older predicate devices, according to Gottlieb and Shuren.


Modernization of the pathway through which most devices undergo FDA reviews is aimed at adapting to the iterative nature of technologies and new complexities facing agency review staff.  The proposed 510(k) changes are also part of a larger initiative set forth via FDA’s medical device safety action plan—updated last week, with a new success measure regarding global impact.

Many predicates that have served as the basis to obtain FDA clearance were established about 40 years ago when Congress created the 510(k) regulatory review process, FDA found.  Device manufacturers tend to “rely on comparative testing vs. predicate devices to show a new device is as safe and effective as the predicate,” Gottlieb Tweeted in November.  “But older predicates might not closely reflect the modern technology embedded in new devices or more current understanding of benefits and risks.”

The 3,173 devices CDRH cleared in 2017 represented 82% of all cleared and approved devices, according to a report issued in conjunction with the 510(k) proposals.  Still, CDRH has eliminated the use of 1,758 devices as predicates for legal use in 510(k)s since the 1976 enactment of the Medical Device Amendments, including 1,477 since 2012, because of safety concerns prompting up-classifications.

Gottlieb offered some examples of devices that have received updates over the years based on older predicates.  “Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate,” Gottlieb and Shuren argued.

The new report revealed CDRH has increased its expectations for 510(k) submissions regarding the quality and quantity of the required information in support of FDA clearance, which in turn has resulted in a current average of 1,185 pages in submitted 510(k)s vs. 475 pages in 2009.  Yet the FDA total time to reach a decision has decreased since 2009, despite a 32% increase in FDA review time.  Quality in 510(k)s has been a longstanding issue facing the agency, with 30% of 510(k)s not accepted for initial FDA review.


From proposed expansions of the Abbreviated 510(k) and the Special 510(k) pathways to the launch of a new Quality in 510(k) Review Program, CDRH has worked to revamp the 510(k) framework in 2018.

Gottlieb and Shuren further noted the proposed changes to the 510(k) program fall within an umbrella of modernization that spans across the regulatory landscape for medical devices.  Other recent policy initiatives are centered on promoting the use of real-world evidence in regulatory decision-making, primarily via an innovation safety net, and introducing a new de novo regulation.

The FDA- and industry-funded safety net, dubbed the National Evaluation System for health Technology (NEST), is reportedly set to open for business during fiscal year 2019.  CDRH also intends to issue a new regulation in upcoming weeks to the de novo program. Updates are intended to accommodate an anticipated increase in manufacturer use of 510(k)s based on the growing body of granted requests on a wide range of devices.  They also seek to provide consistency by codifying the review process and identifying required content to include in requests, as previously reported by RAPS Regulatory Focus.

A shared goal between the 510(k) proposals, NEST and updates to the de novo program relates to improving FDA’s ability to intervene as safety concerns emerge with device use.  “The continued integrity of the 510(k) program, as a means to assure the safety and effectiveness of devices, is a top priority for us, and for the FDA,” Gottlieb and Shuren added.

REFERENCE:  RAPS (Regulatory Focus); 26 NOV 2018; Ana Mulero

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