Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.
【연구 목적】 미국 식품의약청(FDA)은 자기 수술 기구 시스템(Magnetic Surgical Instrument System)을 클래스 II(특수 통제)로 분류하여, 해당 기기의 안전성과 유효성에 대한 합리적인 보장을 제공하고자 한다.
APA
(2016). Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.. Federal register, 81(183), 64761-3.
MLA
. "Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.." Federal register, vol. 81, no. 183, 2016, pp. 64761-3.
PMID
27658314
Abstract
The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 기타 | class II
|
scispacy | 1 |
MeSH Terms
Device Approval; General Surgery; Humans; Laparoscopes; Magnetic Fields; Surgery, Plastic; Surgical Instruments; United States