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General and plastic surgery devices; classification of silicone sheeting. Final rule.

Federal register 2004 Vol.69(152) p. 48146-8
원문 ↗ BibTeX ↓ RIS ↓

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켈로이드 Keloid
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【연구 목적】 식품의약청(FDA)은 폐쇄된 과증식성(비후성 및 반흔성) 흉터 관리에 사용되는 실리콘 시트의 분류를 일반 통제(class I)로 최종 규정하고자 한다.

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BibTeX ↓ RIS ↓
APA (2004). General and plastic surgery devices; classification of silicone sheeting. Final rule.. Federal register, 69(152), 48146-8.
MLA . "General and plastic surgery devices; classification of silicone sheeting. Final rule.." Federal register, vol. 69, no. 152, 2004, pp. 48146-8.
PMID 15300956

Abstract

The Food and Drug Administration (FDA) is classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (general controls). As a class I device, the device will be exempt from premarket notification requirements. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Devices User Fee Modernization Act of 2002 (MDUFMA).

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
합병증 keloid 켈로이드 dict 1
약물 silicone C0037114
silicones
 scispacy 1
약물 silicone sheeting scispacy 1
약물 Act scispacy 1
약물 Food scispacy 1
질환 hypertrophic C0020564
Hypertrophy
 scispacy 1
기타 class I scispacy 1

MeSH Terms

Bandages; Cicatrix, Hypertrophic; Equipment Safety; Humans; Keloid; Product Labeling; Silicones; Surgery, Plastic; United States; United States Food and Drug Administration

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피판재건술 (4) 감염 (3) 색소침착 (3) 비후성흉터 (3) 귀성형술 (3) 유방 (3) 괴사 (2) 안검성형술 (2)

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