ABSTRACT
The few regulatory agencies that have some laser oversight, either users or manufacturers, are also interested in accidents. On the odd chance one is not familiar with CDRH, it means the Center for Devices and Radiological Health and is the branch of the US Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance, and safety of these devices. In addition to reviewing product report submissions, the CDRH also has an Office of Compliance (OC). CDRH, while covering all electronic products, has its strongest emphasis on medical products. Regulatory agencies want to know when things go wrong. The pressure on the medical user is extreme to notify the appropriate agency. In real life, nonmedical reporting has not been as robust or straightforward. Which is an error we all should work to correct.
