Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen
fda-device · Food and Drug Administration · Rule · Published 2021-12-17 · Effective 2021-12-17 · 86 FR 71568
Document
Document number
2021-27317
Federal Register citation
86 FR 71568
CFR reference
21 CFR 878
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-12-17
Effective date
2021-12-17
HHS docket
Docket No. FDA-2021-N-0857
Abstract
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.