[Title 21 CFR D]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 801 - LABELING]
[Subpart D - Exemptions From Adequate Directions for Use]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseDSubpart DFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESLABELING
         Subpart D--Exemptions From Adequate Directions for Use



Sec. 801.109  Prescription devices.

    A device which, because of any potentiality for harmful effect, or 
the method of its use, or the collateral measures necessary to its use 
is not safe except under the supervision of a practitioner licensed by 
law to direct the use of such device, and hence for which ``adequate 
directions for use'' cannot be prepared, shall be exempt from section 
502(f)(1) of the act if all the following conditions are met:
    (a) The device is:
    (1)(i) In the possession of a person, or his agents or employees, 
regularly and lawfully engaged in the manufacture, transportation, 
storage, or wholesale or retail distribution of such device; or
    (ii) In the possession of a practitioner, such as physicians, 
dentists, and veterinarians, licensed by law to use or order the use of 
such device; and
    (2) Is to be sold only to or on the prescription or other order of 
such practitioner for use in the course of his professional practice.
    (b) The label of the device, other than surgical instruments, bears:
    (1) The statement ``Caution: Federal law restricts this device to 
sale by or on the order of a ________'', the blank to be filled with the 
word ``physician'', ``dentist'', ``veterinarian'', or with the 
descriptive designation of any other practitioner licensed by the law of 
the State in which he practices to use or order the use of the device; 
and
    (2) The method of its application or use.
    (c) Labeling on or within the package from which the device is to be 
dispensed 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 practitioners licensed by law to administer the device can use the 
device safely and for the purpose for which it is intended, including 
all purposes for

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which it is advertised or represented: Provided, however, That such 
information may be omitted from the dispensing package if, but only if, 
the article is a device for which directions, hazards, warnings, and 
other information are commonly known to practitioners licensed by law to 
use the device. Upon written request, stating reasonable grounds 
therefor, the Commissioner will offer an opinion on a proposal to omit 
such information from the dispensing package under this proviso.
    (d) Any labeling, as defined in section 201(m) of the act, whether 
or not it is on or within a package from which the device is to be 
dispensed, distributed by or on behalf of the manufacturer, packer, or 
distributor of the device, that furnishes or purports to furnish 
information for use of the device contains adequate information for such 
use, including indications, effects, routes, methods, and frequency and 
duration of administration and any relevant hazards, contraindications, 
side effects, and precautions, under which practitioners licensed by law 
to employ the device can use the device safely and for the purposes for 
which it is intended, including all purposes for which it is advertised 
or represented. This information will not be required on so-called 
reminder--piece labeling which calls attention to the name of the device 
but does not include indications or other use information.
    (e) All labeling, except labels and cartons, bearing information for 
use of the device also bears the date of the issuance or the date of the 
latest revision of such labeling.



Sec. 801.110  Retail exemption for prescription devices.

    A device subject to Sec. 801.109 shall be exempt at the time of 
delivery to the ultimate purchaser or user from section 502(f)(1) of the 
act if it is delivered by a licensed practitioner in the course of his 
professional practice or upon a prescription or other order lawfully 
issued in the course of his professional practice, with labeling bearing 
the name and address of such licensed practitioner and the directions 
for use and cautionary statements, if any, contained in such order.



Sec. 801.116  Medical devices having commonly known directions.

    A device shall be exempt from section 502(f)(1) of the act insofar 
as adequate directions for common uses thereof are known to the ordinary 
individual.



Sec. 801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is 
an in vitro diagnostic product as defined in Sec. 809.3(a) of this 
chapter shall be deemed to be in compliance with the requirements of 
this section and section 502(f)(1) of the act if it meets the 
requirements of Sec. 809.10 of this chapter.



Sec. 801.122  Medical devices for processing, repacking, or manufacturing.

    A device intended for processing, repacking, or use in the 
manufacture of another drug or device shall be exempt from section 
502(f)(1) of the act if its label bears the statement ``Caution: For 
manufacturing, processing, or repacking''.



Sec. 801.125  Medical devices for use in teaching, law enforcement, research, and analysis.

    A device subject to Sec. 801.109 shall be exempt from section 
502(f)(1) of this act if shipped or sold to, or in the possession of, 
persons regularly and lawfully engaged in instruction in pharmacy, 
chemistry, or medicine not involving clinical use, or engaged in law 
enforcement, or in research not involving clinical use, or in chemical 
analysis, or physical testing, and is to be used only for such 
instruction, law enforcement, research, analysis, or testing.



Sec. 801.126  Exemptions for cigarettes and smokeless tobacco.

    Cigarettes and smokeless tobacco as defined in part 897 of this 
chapter are exempt from section 502(f)(1) of the Federal Food, Drug, and 
Cosmetic Act.

[61 FR 44615, Aug. 28, 1996]

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Sec. 801.127  Medical devices; expiration of exemptions.

    (a) If a shipment or delivery, or any part thereof, of a device 
which is exempt under the regulations in this section is made to a 
person in whose possession the article is not exempt, or is made for any 
purpose other than those specified, such exemption shall expire, with 
respect to such shipment or delivery or part thereof, at the beginning 
of that shipment or delivery. The causing of an exemption to expire 
shall be considered an act which results in such device being misbranded 
unless it is disposed of under circumstances in which it ceases to be a 
drug or device.
    (b) The exemptions conferred by Secs. 801.119, 801.122, and 801.125 
shall continue until the devices are used for the purposes for which 
they are exempted, or until they are relabeled to comply with section 
502(f)(1) of the act. If, however, the device is converted, or 
manufactured into a form limited to prescription dispensing, no 
exemption shall thereafter apply to the article unless the device is 
labeled as required by Sec. 801.109.