[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: 21CFR882.1525]

[Page 434]
 
                        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. 882.1525  Tuning fork.

    (a) Identification. A tuning fork is a mechanical device which 
resonates at a given frequency and is used to diagnose hearing disorders 
and to test for vibratory sense.
    (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 the limitations in Sec. 882.9. The device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 66 FR 38807, July 25, 2001]