21 C.F.R. § 880.6730 Body waste receptacle.
Title 21 - Food and Drugs
(a) Identification. A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient. (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 §880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [66 FR 38806, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices
§ 880.6730 Body waste receptacle.
