---
kind: "section"
citation: "21 C.F.R. § 878.3910"
title: "21"
number: "878.3910"
heading: "Noninflatable extremity splint."
url: "https://uscodex.org/cfr/21/878.3910"
---

# §878.3910. Noninflatable extremity splint.

- (a) **Identification.** A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 878.9](/cfr/21/878.9.md). If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000; 90 FR 55986, Dec. 4, 2025]