Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
fda-device · Food and Drug Administration · Rule · Published 2015-10-21 · Effective 2015-10-21 · 80 FR 63671
Document
Document number
2015-26658
Federal Register citation
80 FR 63671
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-10-21
Effective date
2015-10-21
HHS docket
Docket No. FDA-2015-N-3387
Abstract
The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.