---
kind: "section"
citation: "21 C.F.R. § 862.2050"
title: "21"
number: "862.2050"
heading: "General purpose laboratory equipment labeled or promoted for a specific medical use."
url: "https://uscodex.org/cfr/21/862.2050"
---

# §862.2050. General purpose laboratory equipment labeled or promoted for a specific medical use.

- (a) **Identification.** General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
- (b) **Classification.** Class I (general controls). The device is identified in [paragraph (a)](#a) of this section and 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 [§ 862.9](/cfr/21/862.9.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 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001; 90 FR 55980, Dec. 4, 2025]

### Authority

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

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[52 FR 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001; 90 FR 55980, Dec. 4, 2025]