CDRH Clarifies What Success Means for Special 510(k) Pilot

Regulatory NewsRegulatory News | 09 November 2018 |  By 

Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) clarified on Thursday how the center intends to assess the success of its new special 510(k) program pilot based on the types of information to be collected.
Last month, CDRH issued draft guidance to propose certain modifications to the existing special 510(k) program aimed at expanding device eligibility criteria and subsequently launched a new pilot to operationalize the plans. The pilot began 1 October, after which special 510(k)s began being evaluated using the updated eligibility factors, such as labeling changes.
Special 510(k)s submitted to FDA’s Center for Biologics Evaluation and Research (CBER), however, will not undergo regulatory reviews under the pilot, Joshua Silverstein, regulatory advisor at CDRH’s Office of Device Evaluation (ODE) clarified during an FDA workshop Thursday.
The proposed device eligibility expansion will be evaluated via the new pilot to determine whether it will help achieve efficiencies in conducting regulatory reviews on 510(k) submissions.
ODE’s Angela DeMarco outlined the framework CDRH intends to use to evaluate the success of the pilot. The set measures of success are based on the total number of special 510(k)s received, the day a special 510(k) was placed on hold and the total time to decision.
If a submission is deemed inappropriate for a special 510(k) review, CDRH will track the reason for the decision, the day on which the determination was made and the total number of special 510(k)s converted to traditional 510(k)s as part of measuring the pilot’s success.
The special 510(k) paradigm was estalished in 1998 at a time when design control requirements had just been introduced, Silverstein noted. The proposed expansion is intended to better support the purpose of the program through additional criteria for expedited reviews.
A special 510(k) “leverages design control requirements and procedures for FDA to do a summary review for certain within 30 days of receipt,” Silverstein said. The new pilot is not limited to specific product codes or the number of device changes proposed as part of special 510(k)s. Yet CDRH does not believe it would feasible to complete special 510(k) reviews on those that include more than one device change within the 30-day timeframe, Silverstein said. 
According to DeMarco, CDRH has not defined a specific timeframe for the pilot to be completed and will continue to run the pilot until it has sufficient information to determine its success.


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