[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: 21CFR890.5050]

[Page 486]
 
                        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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the current good manufacturing practice regulations in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.