Question

The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported.

A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities

Answer 1

User facilities are not required to notify the FDA if they become aware of information required to be reported under the MDR regulations.

Step-by-step explanation:

The MDR regulations require that user facilities are not required to notify FDA if they become aware of information required to be reported. User facilities are defined as hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment facilities. The other groups mentioned, including manufacturers, distributors, and initial importers, have a responsibility to report any information required by the FDA.