Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
fda-device · Food and Drug Administration · Rule · Published 2024-09-03 · Effective 2024-09-03 · 89 FR 71159
Document
Document number
2024-19722
Federal Register citation
89 FR 71159
CFR reference
21 CFR 890
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-03
Effective date
2024-09-03
HHS docket
Docket No. FDA-2024-N-3946
Abstract
The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression 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 external compression device for internal jugular vein compression'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.