---
kind: "section"
citation: "21 C.F.R. § 888.5940"
title: "21"
number: "888.5940"
heading: "Cast component."
url: "https://uscodex.org/cfr/21/888.5940"
---

# §888.5940. Cast component.

- (a) **Identification.** A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.
- (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 the limitations in [§ 888.9](/cfr/21/888.9.md). The device is also 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

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025]

### Authority

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

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025]