A device which, because of any potentiality for harmful effect,
or the supervision of the method of its use, or the collateral
measures necessary to its use is not safe unless under a practitioner
licensed by law to direct use this device, and hence for which
"adequate directions for use" cannot be written, is
exempt from such provided:
- It is in the possession of either a licensed practitioner or
persons lawfully engaged in the manufacture of distribution of
the product;
- Its labeling bears an Rx statement, i.e., "Caution: Federal
law restricts this device to sale by or on the order of a (Insert name of physician, dentist or other licensed practitioner;"
- Its labeling bears information for use including, indications,
effects, routes, methods, and frequency and duration of administration,
and any relevant hazards, contraindications, side effects, and
precautions under which the device can safely be used; and
- All labeling other than labels and carton bears the date of
issuance or date of the latest revision.
A device which is delivered to the ultimate user by a licensed
practitioner in the course of their practice or upon prescription
are required only to bear the name and address of the practitioner,
directions for use, and any required cautionary statements.
Are exempt from adequate directions for use provided that
they meet those requirements found in 21 CFR 809.10(covered in the "In
Vitro Diagnostic Product Labeling" section this chapter).
Devices used for processing, repacking, or manufacturing of
another drug or device are exempt from adequate directions for
use if they bear the statement: "Caution: For manufacturing,
processing, or repacking."
Medical Devices Used in Teaching, Research,
or Law Enforcement 21
CFR 801.125
Devices for use in teaching, law enforcement, research, and
analysis are exempt if the device is shipped or sold to, or in
the possession of, persons lawfully engaged in instruction in
pharmacy, chemistry, or medicine (not involving clinical use),
law enforcement, or chemical analysis or physical testing.
