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Title 21 Part 880 → Subpart G → §880.6992

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6992

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6992

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

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6992


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


§880.6992   Medical washer-disinfector.

(a) Identification. A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”

(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

(2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §880.9.

[67 FR 69121, Nov. 15, 2002]