Page 77 - Biomedical Engineering and Design Handbook Volume 2, Applications

56 MEDICAL DEVICE DESIGN

• A user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic
facility, or outpatient treatment facility, which is not a physician’s office. School nurse offices and
employee health units are not device user facilities.
• An importer means any person 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, but who does not repackage or otherwise change the
container, wrapper, or labeling of the device or device package. If you repackage or otherwise
change the container, wrapper, or labeling, you are considered a manufacturer as defined in
this section.
• A manufacturer means any person who manufactures, prepares, propagates, compounds, assem-
bles, or processes a device by chemical, physical, biological, or other procedure.
The term includes any person who
(a) Repackages or otherwise changes the container, wrapper, or labeling of a device in further-
ance of the distribution of the device from the original place of manufacture.
(b) Initiates specifications for devices that are manufactured by a second party for subsequent
distribution by the person initiating the specifications.
(c) Manufactures components or accessories that are devices that are ready to be used and are
intended to be commercially distributed and intended to be used as is, or are processed by a
licensed practitioner or any other qualified person to meet the needs of a particular patient.
(d) Is U.S. agent of a foreign manufacturer.

These entities must report when they “become aware” of one of the reportable events. To become
aware means that an employee of the entity required to report has acquired information that reason-
ably suggests a reportable adverse event has occurred:
• If you are a device user facility, you are considered to have become aware when medical person-
nel who are employed by or otherwise formally affiliated with your facility, obtain information
about a reportable event.
• If you are a manufacturer, you are considered to have become aware of an event when any of your
employees becomes aware of a reportable event that is required to be reported within 30 calen-
dar days or that is required to be reported within 5 work days because reports had been requested
in accordance with 803.53(b). You are also considered to have become aware of an event when
any of your employees with management or supervisory responsibilities over persons with regu-
latory, scientific, or technical responsibilities, or whose duties relate to the collection and report-
ing of adverse events, becomes aware, from any information, including any trend analysis, that a
reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of
substantial harm to the public health.
• If you are an importer, you are considered to have become aware of an event when any of your
employees becomes aware of a reportable event that is required to be reported by you within 30
days.

This casts a very wide net. Awareness by any employee may trigger a statutory obligation.
Who must report to whom may be summarized by
(a) If you are a device user facility, you must submit reports as follows:
(1) Submit reports of individual adverse events no later than 10 work days after the day that you
become aware of a reportable event:
(i) Submit reports of device-related deaths to FDA and to the manufacturer, if known; or
(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer
is unknown, submit reports to FDA.
(2) Submit annual reports to FDA.