Skip to main content
MITA supports FDA report on medical device servicing

An FDA report saying the agency will advocate quality management principle adoption for medical device servicers; clearly explain the difference between remanufacturing and servicing; improve medical device servicing-related cybersecurity practices; and promote the development of evidence for evaluating servicing quality, safety and effectiveness, has received the support of the Medical Imaging and Technology Alliance. However, MITA urged Congress to approve bipartisan legislation mandating third-party servicers to register with the FDA, report adverse events and manage complaint handling systems.

Full Story: