Meeting Planned on Notification Guidelines for Cardiac Devices

A plan to have CDRH’s Office of Device Evaluation (ODE) review 30-day notices of manufacturing changes, rather than the Office of Compliance, will first be piloted in the cardiovascular devices division. The switch in responsibility “is in line with the agency’s intention to focus on the total product lifecycle, such that the same reviewers that review the original marketing submission are looking at the safety and effectiveness of changes,” FDA spokeswoman Michelle Bolek said.
Devices & Diagnostics Letter