[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: 21CFR890.5050]

[Page 526]
 
                        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 F_Physical Medicine Therapeutic Devices
 
Sec. 890.5050  Daily activity assist device.


    (a) Identification. A daily activity assist device is a modified 
adaptor or utensil (e.g., a dressing, grooming, recreational activity, 
transfer, eating, or homemaking aid) that is intended for medical 
purposes to assist a patient to perform a specific function.
    (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. 890.9. If the device 
is not labeled or otherwise represented as sterile, 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 66 FR 38817, July 25, 2001]