MassDevice reports that the results of the FDA's internal study of the 510(k) process may be available in the next few weeks. While CDRH director Jeff Shuren has kept quiet on any potential changes that may be implemented (the center had previously targeted September for certain revisions to the process), he did confirm that "we're not recommending to get rid of the 510(k) program."
Quoted at a Massachusetts town hall meeting, Shuren spoke to increasing data requirements for devices cleared under the 510(k), saying that the agency's goal is to be clear about the cases where additional data will be required. He confirmed that the agency is working toward "clear, predictable pathways to approval and clearance." Shuren added that it wasn't the ReGen debacle that spurred the review. "These issues we uncovered in 510(k) were circling around for a while," he said.
In addition to conducting the internal review, the FDA has commissioned the IOM to conduct its own study of the 510(k) process. There has been speculation that the changes due this fall will be "no brainers", while more controversial recommendations will be left for the IOM.
