# Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device
> **Food and Drug Administration** · Final order. · Published 2018-10-19 · Effective 2018-10-19 · 83 FR 52966
## Document
- **Document number:** 2018-22837
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 52966
- **CFR reference:** 21 CFR 878
- **Publication date:** 2018-10-19
- **Effective date:** 2018-10-19
- **HHS docket:** Docket No. FDA-2018-N-3696
## Abstract

The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/10/19/2018-22837/medical-devices-general-and-plastic-surgery-devices-classification-of-the-wound-autofluorescence)
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