---
kind: "section"
citation: "21 C.F.R. § 890.3420"
title: "21"
number: "890.3420"
heading: "External limb prosthetic component."
url: "https://uscodex.org/cfr/21/890.3420"
---

# §890.3420. External limb prosthetic component.

- (a) **Identification.** An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.
- (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 [§ 890.9](/cfr/21/890.9.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

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025]

### Authority

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

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025]