[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: 21CFR860.1]

[Page 158-159]
 
                        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.
    (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

[[Page 159]]

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.