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US FDA Regulation 관련 링크

Jul 20, 2020 — 2 min read

SooYoung Kwak

미국 FDA의 규제 절차 및 허가 신청과 관련된 링크 모음입니다.






FD & C Act vs FDA Regulation vs FDA guidance


  1. FD & C Act와 FDA Regulation, FDA Guidance의 소개 및 설명

2. FDA가 관할하는 법(Laws enforced by FDA)에 소개





Federal Food, Drug, and Cosmetic Act


  • 미의회가 제정하는 연방법(federal law enacted by Congress)

  • US FDA의 기능에 대한 법적 근거가 됨(with other federal laws, this establish the legal framework within which FDA operates)

  • are codified into Title 21 Chapter 9 of the United States Code (미국 법 the laws of the US Code 중 Title 21 Chapter 9가 FD& C Act)

  • 참조 링크





FDA regulations


  • 또 다른 연방법인 Administrative Procedure Act에서 요구되는 절차를 따라 제정(follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations)

  • FD&C Act의 한 부분인 것은 아님(also federal laws, but they are not part of the FD&C Act)

  • can be found in Title 21 of the Code of Federal Regulations(CFR)

  • 참조 링크






FDA guidance


  • 가이던스 출판 시 “Good Guidance Practice” 에 규정된 절차를 따름(FDA follows the procedures required by its “Good Guidance Practice” regulation to issue FDA guidance)

  • 규제 이슈에 대한 FDA의 현재 시각을 설명함(describes the agency’s current thinking on a regulatory issue)

  • 법적 구속력이 있는 것은 아님(is not legally binding on the public or FDA)

  • 참조 링크 (Good Guidance Practice)

  • 참조링크 (Clinical Trials Guidance Documents)






FDA submission 관련


  1. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

2. The Special 510(k) Program

3. eCopy Program for Medical Device Submissions






FDA 21st Century Cures Act



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