[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: 21CFR860.1]

[Page 173-174]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 860_MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                            Subpart A_General
 
Sec. 860.1  Scope.


    (a) This part implements sections 513, 514(b), 515(b), and 520(l) of 
the act with respect to the classification and reclassification of 
devices intended for human use.

[[Page 174]]

    (b) This part prescribes the criteria and procedures to be used by 
classification panels in making their recommendations and by the 
Commissioner in making the Commissioner's determinations regarding the 
class of regulatory control (class I, class II, or class III) 
appropriate for particular devices. Supplementing the general Food and 
Drug Administration procedures governing advisory committees (part 14 of 
this chapter), this part also provides procedures for manufacturers, 
importers, and other interested persons to participate in proceedings to 
classify and reclassify devices. This part also describes the kind of 
data required for determination of the safety and effectiveness of a 
device, and the circumstances under which information submitted to 
classification panels or to the Commissioner in connection with 
classification and reclassification proceedings will be available to the 
public.