21 CFR 880.6992
Medical washer-disinfector
21 CFR 880.6992 is the regulation titled “Medical washer-disinfector” in 21 CFR Part 880, General Hospital and Personal Use Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.39, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite 21 CFR 880.6992 most often, as written in the letters.
- 1 letterthe device is not exempt because it is not the type of device that is within the generic category of devices identified under § 880.6992. Generic devices of this type include functional steps that utilize mechanical…
The regulation
Read the text of 21 CFR 880.6992 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 880.6992.
Latest letters citing it
The letter citing 21 CFR 880.6992 that FDA posted most recently.
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