[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.5]

[Page 15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 801.5  Medical devices; adequate directions for use.

    Adequate directions for use means directions under which the layman 
can use a device safely and for the purposes for which it is intended. 
Section 801.4 defines intended use. Directions for use may be inadequate 
because, among other reasons, of omission, in whole or in part, or 
incorrect specification of:
    (a) Statements of all conditions, purposes, or uses for which such 
device is intended, including conditions, purposes, or uses for which it 
is prescribed, recommended, or suggested in its oral, written, printed, 
or graphic advertising, and conditions, purposes, or uses for which the 
device is commonly used; except that such statements shall not refer to 
conditions, uses, or purposes for which the device can be safely used 
only under the supervision of a practitioner licensed by law and for 
which it is advertised solely to such practitioner.
    (b) Quantity of dose, including usual quantities for each of the 
uses for which it is intended and usual quantities for persons of 
different ages and different physical conditions.
    (c) Frequency of administration or application.
    (d) Duration of administration or application.
    (e) Time of administration or application, in relation to time of 
meals, time of onset of symptoms, or other time factors.
    (f) Route or method of administration or application.
    (g) Preparation for use, i.e., adjustment of temperature, or other 
manipulation or process.