The Safe Medical Device Act of 1990 requires reporting of incidents involving a medical device...

The Safe Medical Device Act (SMDA) of 1990 requires healthcare facilities to report to the FDA and the manufacturer when a device is suspected of causing or contributing to death or serious injury.

C. death or injury (Correct): Specifically mandated under SMDA.

A. inappropriate application: A usage issue, not a reporting trigger.

B. recall: Issued by the FDA/manufacturer, not the facility’s reporting obligation.

D. major breakdown: Requires service but not mandatory reporting.