We're from the government, we are here to help you...

CDRH Touts Proposed 510(k) Changes as Good News for Device Industry
CDRH is trying to sell devicemakers on suggested changes to the 510(k) process, saying the changes would increase regulatory predictability. “It is not our intent to turn the world upside down for device manufacturers,” Christy Foreman, acting director of CDRH’s Office of Device Evaluation, said during an agency webinar last week. CDRH officials promoted the upsides of a Class IIb process for 510(k) devices that are more likely to require additional clinical information, touting it as a step toward global harmonization. Having such harmonization could lead to devices being simultaneously cleared domestically and abroad, CDRH Director Jeffrey Shuren said.
Devices & Diagnostics Letter