Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.
【연구 목적】 미국 식품의약국(FDA)은 흡수성 폐 생검 플러그(absorbable lung biopsy plug)의 안전성과 유효성을 합리적으로 보장하기 위해 이를 클래스 II(특수 통제)로 분류하는 최종 명령을 내렸다.
APA
(2014). Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.. Federal register, 79(46), 13218-20.
MLA
. "Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.." Federal register, vol. 79, no. 46, 2014, pp. 13218-20.
PMID
24693559
Abstract
The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug 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 absorbable lung biopsy plug'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 | lung biopsy
|
scispacy | 1 | ||
| 기타 | class II
|
scispacy | 1 |
MeSH Terms
Absorbable Implants; Biopsy; Device Approval; Equipment Safety; Humans; Lung; Surgery, Plastic; Surgical Instruments; United States