21 CFR 882.1540
Galvanic skin response measurement device
21 CFR 882.1540 is the regulation titled “Galvanic skin response measurement device” in 21 CFR Part 882, Neurological Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, 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
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 882.1540 (eCFR, as of Sep 1, 2026)
(a) Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 882.1540.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.120Device labeling1 letter cites both
- 21 CFR 820.184Device history record1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.3Definitions1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 882.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)1 letter cites both
Latest letters citing it
The letter citing 21 CFR 882.1540 that FDA posted most recently.
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