Some of the important changes proposed by FDA’s report include the following:
 
Introduction of Class IIb Devices. These devices, which may include implantable or life-sustaining devices, would usually require the submission of clinical data and manufacturing data in the 510(k) notice, as well as be subject to additional postmarket requirements. Condition-of-clearance studies are suggested by the report. The report recommends a requirement for manufacturers to provide regular, periodic updates on device modifications made postmarket, to be applied initially to Class IIb devices.
 
Limiting Split and Multiple Predicates. The group recommends limiting multiple predicates used to support substantial equivalence, and potentially disallowing the practice of split predicates (i.e., using one predicate for intended use and another for technological characteristics). The report notes an analysis showing that citing more than five predicates in a 510(k) is associated with increased adverse events. The report recommends developing guidance on when predicates may no longer be used (e.g., if a device has been removed from the market for safety concerns.)
 
Clarifying Substantial Equivalence. Insufficient clarity with respect to critical terms in the statutory definition of substantial equivalence has, in some cases, contributed to inconsistency in CDRH’s 510(k) decision making, internal and external debates, and delays in review. As the 510(k) standard has been applied to a wider range of devices over time, including increasingly varied, complex, and potentially higher-risk technologies, the need for greater clarity has become even more pressing. The 510(k) Working Group recommends that CDRH more clearly define these terms in guidance and training for review staff and industry.
 
Changing Intended Use. Combining the concepts of intended use and indications for use to address the concern that future minor labeling changes could be considered a new intended use. The report suggests training for reviewers regarding what elements of a 510(k) can be used to determine intended use, including “device design (explicit or implicit)” and literature. In addition, the report recommends a statutory amendment that would allow the agency to consider off-label uses of a device in a 510(k) review.
 
Streamlining the De Novo Process. Acknowledging the lengthy review times and unclear requirements of the de novo 510(k) process, the working group proposes streamlining the process and clarifying the agency’s expectations with regard to these devices. One option mentioned is creating a generic set of special controls for devices that are cleared via this process, to be supplemented by device-specific special controls.
 
Requiring Complete Safety and Effectiveness Information. The working group recommends that CDRH consider revising existing regulations to explicitly require 510(k) submitters to provide in their 510(k)s a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and effectiveness of the device under review.
 
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