One who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. Also includes U.S. agents of foreign manufactures, those who establish specifications for devices manufactured by another party and who then distribute those devices, and those who repackage or otherwise change the container, wrapper, or labeling of a device.
One who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user. Does not include those who repackage or otherwise change the container, wrapper, or labeling of the device or device package.
One who furthers the marketing of a device from the manufacturer to the entity that makes final delivery or sale to the ultimate user.
Device user facility
A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility.a Does not include physician’s offices, school nurse offices, or employee health units.
Box 3.1 defines several terms used in the reporting regulations. Under FDA regulations, home health care agencies are considered to be user facilities. Those who supply medical equipment to patient’s homes are considered to be distributors.
Box 3.2 summarizes adverse event reporting requirements for medical