Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
fda-device · Food and Drug Administration · Rule · Published 2020-01-22 · Effective 2020-01-22 · 85 FR 3543
Document
Document number
2020-00496
Federal Register citation
85 FR 3543
CFR reference
21 CFR 892
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2020-01-22
Effective date
2020-01-22
HHS docket
Docket No. FDA-2019-N-5589
Abstract
The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.