Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device
fda-device · Food and Drug Administration · Rule · Published 2018-10-19 · Effective 2018-10-19 · 83 FR 52966
Document
Document number
2018-22837
Federal Register citation
83 FR 52966
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
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.