[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.1]

[Page 185-186]
 
                        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. 861.1  Purpose and scope.


    (a) This part implements section 514 of the Federal Food, Drug, and 
Cosmetic Act (the act) with respect to the establishment, amendment, and 
revocation of performance standards applicable to devices intended for 
human use.
    (b) The Food and Drug Administration may determine that a 
performance standard, as described under special controls for class II 
devices in Sec. 860.7(b) of this chapter, is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Performance standards may be established for:
    (1) A class II device;
    (2) A class III device which, upon the effective date of the 
standard, is reclassified into class II; and
    (3) A class III device, as a condition to premarket approval under 
section 515 of the act, to reduce or eliminate a risk or risks 
associated with such device.
    (c) References in this part to regulatory sections of the Code of 
Federal

[[Page 186]]

Regulations are to chapter I of title 21 unless otherwise noted.

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 
FR 58404, Dec. 10, 1992]