The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to largely rely on declarations of conformity and/or summary data. Though attractive, the proposed program raises certain regulatory and business questions for manufacturers of class II devices.
On April 12, 2018, FDA issued the draft guidance, “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.” The program introduced by the guidance expands on the current Abbreviated 510(k) Program. Under the Abbreviated 510(k) Program, a submitter can use conformity to objective performance criteria (OPC) to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence. However, aspects of the device for which no OPC exist under the Abbreviated 510(k) Program must be addressed by a traditional comparison to a legally marketed predicate device. In contrast, under the Expanded Abbreviated 510(k) Program described in the guidance, a manufacturer could receive a substantial equivalence determination from FDA by conforming with OPC that address all relevant performance characteristics of a given device type. The OPC could take the form of guidance, consensus standards, or special controls. Conformance to the OPC could be demonstrated through declarations of conformity, summary data, and/or underlying data, as appropriate.
Under the Expanded Abbreviated 510(k) Program, FDA would essentially substitute a set of OPC for a predicate device as a basis to determine substantial equivalence (though a predicate device would still be identified for the limited purposes of the intended use and technological characteristics prongs of the substantial equivalence analysis). Until now, most 510(k) submissions have relied on comparison testing against similar predicate devices to establish substantial equivalence. However, FDA has become increasingly concerned that predicate devices chosen for comparison testing purposes can often be older devices that may not closely reflect newer technologies on the market. The guidance cites the agency’s least burdensome principles to explain the benefits that comparing a device to a set of OPC can provide to a manufacturer. Principally, the time to bring a class II device to market could be reduced by streamlining FDA review and facilitating the evaluation between the subject device and its comparator. For example, testing a subject device against a substantial number of predicates to demonstrate substantial equivalence may be more burdensome and with less regulatory certainty than an evaluation against an established set of parameters blessed by the agency. Availing a set of OPC as a comparator for purposes of determining substantial equivalence also benefits the agency beyond streamlining FDA review, as it provides a method for the agency to promote device quality. A quicker path to market founded on a set of OPC selected by FDA creates incentives for the commercialization of devices satisfying the agency’s quality baseline.
At the same time, there exist certain regulatory and business questions as to how the Expanded Abbreviated 510(k) Program will be implemented. First, what criteria will FDA use to select the relevant OPC for a given device? The guidance states, “FDA intends to rely on the experience and expertise of FDA staff, information in literature, and analyses of data on existing devices within a device type to determine the performance criteria and associated testing methods that could support a finding of substantial equivalence for a given device type.” However, these considerations relate more to sources of information than a standard for FDA’s designation of a characteristic as an objective performance criterion. Similarly, how will device types be selected for eligibility in the Expanded Abbreviated 510(k) Program?
In addition, although the guidance stresses that the Traditional 510(k) route would remain an option for those devices eligible for review under an Expanded Abbreviated 510(k) Program, use of the former pathway may raise questions with stakeholders. The guidance states that the Expanded Abbreviated 510(k) Program “could facilitate healthcare professionals and patients making better informed decisions by ensuring that a device cleared through this pathway meets a transparent set of performance criteria.” The implication is that the general public could ascertain whether a device eligible for the Expanded Abbreviated 510(k) Program was cleared by conformance with OPC or cleared by comparison with a legally marketed device under a Traditional 510(k). Eligible devices cleared under a Traditional 510(k) could end up being perceived as unable to satisfy OPC and therefore forced to resort to the Traditional 510(k) pathway. In turn, manufacturers of eligible devices that were cleared under a Traditional 510(k) may be expected to explain to stakeholders how their device compares to the relevant OPC.
Aside from important regulatory and business questions prompted by the guidance, the proposed policy is nevertheless another agency step towards reducing barriers to marketing class II devices. Other recent device de-regulatory actions include the Digital Heath Pre-Certification Pilot Program, aimed at reducing pre-market review for certain qualified digital health manufacturers, and a Federal Register notice announcing a slew of class II devices that no longer require FDA pre-market review.
Though the policy is novel, the new pathway to market should not come as a surprise as Commissioner Gottlieb described the concept in an FDA blog post and the explicit title of the guidance has been listed as a high priority on CDRH’s FY2018 guidance agenda since December 2017. Two other guidances on the Center’s high priority list include “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” and “Principles and Procedures for the Recognition and/or Withdrawal of Voluntary Consensus Standards.” As a form of OPC, standards will play an even larger role in how FDA regulates devices, an expansion supported by the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act of 2017. Collectively, both pieces of legislation include mandates and funding intended to enhance the CDRH Standards Program.
One provision in particular has the potential to influence the Expanded Abbreviated 510(k) Program. Under Section 3053 of the 21st Century Cures Act, any person can request that CDRH formally recognize a consensus standard and the agency must, in turn, provide its rationale for recognizing all, part, or none of the standard, including the scientific, technical, regulatory, or other basis for that decision. We foresee stakeholders utilizing this provision to help shape the OPC that FDA will use when evaluating substantial equivalence under the Expanded Abbreviated 510(k) Program.
The deadline for submitting comments to the draft guidance is July 11, 2018.