---
kind: "section"
citation: "21 C.F.R. § 878.4550"
title: "21"
number: "878.4550"
heading: "Autofluorescence detection device for general surgery and dermatological use."
url: "https://uscodex.org/cfr/21/878.4550"
---

# §878.4550. Autofluorescence detection device for general surgery and dermatological use.

- (a) **Identification.** An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
  - (6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
  - (7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
  - (8) Labeling must include the following:
    - (i) Instructions for use;
    - (ii) The detection performance characteristics of the device when used as intended; and
    - (iii) **A shelf life for any sterile components.**

## Notes

### Amendments

[87 FR 24273, Apr. 25, 2022]

### 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

[87 FR 24273, Apr. 25, 2022]