[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.7]

[Page 177-178]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents
 
                           Subpart A--General
 
Sec. 861.7  Contents of standards.

    Any performance standard established under this part will include 
such provisions as the Food and Drug Administration determines are 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device or devices for which it is established. 
Where necessary to provide such assurance, a standard will address (but 
need not be limited to):
    (a) Performance characteristics of the device;
    (b) The design, construction, components, ingredients, and 
properties of the device, and its compatibility with power systems and 
connections to such systems;
    (c) The manufacturing processes and quality control procedures 
applicable to the device;
    (d) Testing of the device on either a sample or a 100-percent basis 
by the manufacturer, or, if it is determined that no other more 
practical means are available to the Food and Drug Administration to 
assure the conformity of the device to the standard, providing for 
testing by the Food and Drug Administration or a third person to ensure 
that the device conforms to the standard;
    (e) The publication of the results of each test or of certain tests 
of the device to show that the device conforms to the portions of the 
standard for which the test or tests were required;
    (f) Manufacturers' certification to purchasers or to the Food and 
Drug Administration that the device conforms to the applicable 
performance standard;
    (g) Restrictions on the sale and distribution of the device, but 
only to the extent authorized under section 520(e) of the act;

[[Page 178]]

    (h) The use, and the form and content, of labeling for the proper 
installation, maintenance, operation, and use of the device. Among the 
provisions that may be required in the labeling are warnings; storage 
and transportation information; expiration dates; the date and place of 
manufacture; the results that may be expected if the device is used 
properly; the ranges of accuracy of diagnostic information; instructions 
regarding the proper care of, and the proper components, accessories, or 
other equipment to be used with the device; and statements concerning 
the appropriate patient population, for example, a statement that the 
device is considered safe and effective only when used by, or in the 
treatment of, a patient who has been tested by particular designated 
procedures and found to have an illness or condition for which use of 
the device is indicated by a person skilled in the use of the device.