[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: 21CFR860.93]

[Page 165-166]
 
                        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 B--Classification
 
Sec. 860.93  Classification of implants, life-supporting or life-sustaining devices.

    (a) The classification panel will recommend classification into 
class III of any implant or life-supporting or life-sustaining device 
unless the panel determines that such classification is not

[[Page 166]]

necessary to provide reasonable assurance of the safety and 
effectiveness of the device. If the panel recommends classification or 
reclassification of such a device into a class other than class III, it 
shall set forth in its recommendation the reasons for so doing together 
with references to supporting documentation and data satisfying the 
requirements of Sec. 860.7, and an identification of the risks to 
health, if any, presented by the device.
    (b) The Commissioner will classify an implant or life-supporting or 
life-sustaining device into class III unless the Commissioner determines 
that such classification is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. If the 
Commissioner proposes to classify or reclassify such a device into a 
class other than class III, the regulation or order effecting such 
classification or reclassification will be accompanied by a full 
statement of the reasons for so doing. A statement of the reasons for 
not classifying or retaining the device in class III may be in the form 
of concurrence with the reasons for the recommendation of the 
classification panel, together with supporting documentation and data 
satisfying the requirements of Sec. 860.7 and an identification of the 
risks to health, if any, presented by the device.