Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.
【연구 목적】 미국 식품의약청(FDA)은 내부 조직 마커(internal tissue marker)를 특수 통제(special controls)가 적용되는 제2군(class II) 의료기기로 분류하여, 해당 기기의 안전성과 유효성에 대한 합리적인 보장을 제공하고자 한다.
APA
(2015). Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.. Federal register, 80(150), 46485-6.
MLA
. "Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.." Federal register, vol. 80, no. 150, 2015, pp. 46485-6.
PMID
26245004
Abstract
The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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 |
|---|---|---|---|---|---|
| 해부 | Tissue
|
scispacy | 1 | ||
| 기타 | class II
|
scispacy | 1 |
MeSH Terms
Coloring Agents; Equipment Safety; Humans; Surgery, Plastic; Surgical Equipment; United States