Health and Human Services Department Docket FDA-2021-N-0857 Final Rule

2021-27317: Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen

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Summary

The Food and Drug Administration (FDA or we) is classifying the manual percutaneous surgical set assembled in the abdomen 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 manual percutaneous surgical set assembled in the abdomen'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.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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