FDA’s CDRH Increasing Medical Device Inspections

FDA’s CDRH announced an increasing number of inspections of medical device manufacturers for a targeted risk-based approach for improved compliance in their recent Medical Device Enforcement and Quality Report. Since 2007, the FDA has increased its annual number of device inspections by 46 percent and has increased annual inspections of foreign firms by 243 percent. Will your firm be ready when FDA knocks on your door? Learn more from Bryan J. Coleman, EAS Senior Director for Pharmaceutical and Medical Devices in this Hot Topic report.