FDA Expands the Special 510k Process
​[Thursday, October 4, 2018]

Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process to include most modifications of previously approved 510k devices. The special 510k filed under the pilot program will be reviewed within 60 days. The special 510k allows FDA to approve a new device based on review of design control requirements and previous FDA review of detailed information for the predicate device, thereby reducing review times. For a device to the eligible for the pilot program, it would need to be submitted by the same company that originally got the approval for the existing device that is being modified. The manufacturer will need to demonstrate that “performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and that all performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.” The pilot program is only available to non-diagnostic devices regulated entirely by the CDRH. All Special 510(k)s submitted to CDRH will be considered as part of the pilot. The pilot program will be granted a permanent status based on the results of the pilot program. This was a much desired, long awaited program for increase the efficiency of the 510k program.