CDRH Following Up More Actively On Complaints Against Device Manufacturers

摘要

Hundreds of complaints against manufacturers routinely flood FDA's device center, many leading to facility inspections and agency enforcement actions.Complaints can come from a variety of sources, including competitors, product users and whistleblowers, to name just a few.Now the center has a new system to triage complaints so it can focus on those representing the highest risk to patient safety, said Ann Ferriter, director for the Division of Risk Management Operations in CDRH's Office of Compliance.