Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device. Final order.
【연구 목적】 미국 식품의약국(FDA)은 상처 자가형광 이미징 장치(wound autofluorescence imaging device)를 의료기기 분류 체계상 Class I로 분류하는 최종 명령을 내렸다.
APA
(2018). Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device. Final order.. Federal register, 83(203), 52966-8.
MLA
. "Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device. Final order.." Federal register, vol. 83, no. 203, 2018, pp. 52966-8.
PMID
30358383
Abstract
The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I 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, in part by reducing regulatory burdens.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 합병증 | Wound
|
scispacy | 1 | ||
| 약물 | FDA
|
scispacy | 1 | ||
| 기타 | class I.
|
scispacy | 1 | ||
| 기타 | class I
|
scispacy | 1 |
MeSH Terms
Equipment Safety; Fluorescence; General Surgery; Humans; Optical Imaging; Surgery, Plastic; Wounds and Injuries