21 CFR 890.3475
Limb orthosis
21 CFR 890.3475 is the regulation titled “Limb orthosis” in 21 CFR Part 890, Physical Medicine 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
- 100% 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
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 890.3475 (eCFR, as of Sep 1, 2026)
(a) Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
(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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.3475.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
- 21 CFR 876.5020External penile rigidity devices1 letter cites both
Latest letters citing it
The letter citing 21 CFR 890.3475 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.