FDA's attempts to rein in the 510(k) program encountered a large obstacle in the form of the Food and Drug Administration Safety and Innovation Act of 2012, and the agency's new report on the 510(k) program acknowledges that the 2011 draft guidance on changes to 510(k) devices came up short. The report's executive summary states that FDA "intends to make targeted revisions to the 1997 guidance" rather than attempt to come up with an entirely new framework, and promised that the agency "intends to adopt a policy that will leverage existing quality system requirements" to deal with changes to 510(k) devices. Read More
