Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the external compression device for internal jugular vein compression, (Sep 6, 2024)

By WK Editorial Staff

The FDA notes the action will also enhance patients’ access to beneficial innovative devices.

The FDA has classified the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type will be part of the codified language for the external compression device for internal jugular vein compression’s classification. The FDA is taking this action because it determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device (Final Rule, 89 Fed. Reg. 71159 (Sept. 3, 2024)).

Dates. This order is effective September 3, 2024. The classification was applicable on February 26, 2021.

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