AdvaMed is pushing back on an initiative in Congress to have the FDA to tighten policies for approving modifications of on-the-market medical devices. In an article in FierceMedicalDevices, AdvaMed contends there is nothing wrong with the current 510(k) program. AdvaMed contends the system has worked well for 16 years, so no changes are needed.
Topics: AdvaMed, FierceMedicalDevices, FDA, 510(k)