CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART F—General Hospital and Personal Use Therapeutic Devices (§880.5025 to §880.5970) > 880.5075—Elastic bandage.

880.5075—Elastic bandage.

(a) Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
(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 requirements of the quality system regulation 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.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]