BOX 3.1
Selected Definitions Related to Medical Device Reporting Requirements

Manufacturer

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.

Importer

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.

Distributor

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.

Reportable event

  1. An event about which a user facility becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

  2. An event about which a manufacturer or importer has received or become aware of information that reasonably suggests that one of its marketed devices:

    1. may have caused or contributed to a death or serious injury; or

    2. has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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



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