---
kind: "section"
citation: "21 C.F.R. § 880.6992"
title: "21"
number: "880.6992"
heading: "Medical washer-disinfector."
url: "https://uscodex.org/cfr/21/880.6992"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[67 FR 69121, Nov. 15, 2002]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[67 FR 69121, Nov. 15, 2002]