Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point
fda-device · Food and Drug Administration · Rule · Published 2022-12-27 · Effective 2022-12-27 · 87 FR 79253
Document
Document number
2022-28131
Federal Register citation
87 FR 79253
CFR reference
21 CFR 870
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-12-27
Effective date
2022-12-27
HHS docket
Docket No. FDA-2022-N-3130
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive hemodynamic indicator with decision point 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 adjunctive hemodynamic indicator with decision point'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.