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Title 21 Part 880 → Subpart G → §880.6450

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6450

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6450

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6450


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


§880.6450   Skin pressure protectors.

(a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

(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 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 66 FR 38806, July 25, 2001]