[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3700]

[Page 483]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart D--Physical Medicine Prosthetic Devices
 
Sec. 890.3700  Nonpowered communication system.

    (a) Identification. A nonpowered communication system is a 
mechanical device intended for medical purposes that is used to assist a 
patient in communicating when physical impairment prevents writing, 
telephone use, reading, or talking. Examples of nonpowered 
communications systems include an alphabet board and a page turner.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989]

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