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Title 21 Part 880 → Subpart G → §880.6060

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6060

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6060

e-CFR data is current as of September 13, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6060


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6060   Medical disposable bedding.

(a) Identification. Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

(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. If the device is not labeled or otherwise represented as sterile, it is also 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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]