[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: 21CFR882.1200]

[Page 404]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882--NEUROLOGICAL DEVICES--Table of Contents
 
               Subpart B--Neurological Diagnostic Devices
 
Sec. 882.1200  Two-point discriminator.

    (a) Identification. A two-point discriminator is a device with 
points used for testing a patient's touch discrimination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9. The device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 65 FR 2319, Jan. 14, 2000]