You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the ...
(g) Labeling requirements 1040.10(h)(1) User information 1040.11(a) Medical laser products * Manufacturers should apply the interpretation sheets IEC 60825-1/ISH1:Interpration sheet 1 – Safety of laser products – Part 1: Equipment classification and requirements and IEC 60825-1/ISH2: ...
美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
Because you failed to correct repeat violations, we strongly recommend engaging a consultant as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management ...
器械建议的标识要求/ Labelingrequirements from Device Advice ---完--- 医疗器械从业者Medical Device Practitioner “专注、专业、分享、成长":专注医疗器械行业领域,学习、分享专业资讯、知识、技能,促进医疗器械从业者自我成长与提升。欢迎医疗器械行业的研发、注册、法规、体系、品质、工艺、生产、采购、HR等医疗器械...
An alternative approach may be used if such approach satisfies the requirements of the applicable statues. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent. 本指南中所指的“制造”包括物料接收、生产、包装、重新包装、贴签、...
product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements...
A.The Deeming Rule已经编入法典the Code of Federal Regulations,1100(the deeming provisions)、1140(sales and distribution restrictions)、1143 (warning label requirements)部分。关于The Deeming Rule的详细解释可以参考下面网址: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395...
country of origin within the meaning of *CBP's* labeling requirements, 19 CFR 134.1(b) and 134.11. As a result of *CBP's* seizure actions and other regulatory follow-up involving imported shrimp that was peeled, deveined, and repacked in the United States and labeled as a product of ...
l“abeling A drug product is misbranded if its abeling is false or misleading in any particular is false or misleading in any particular [502(a)][502(a)] ”and fails to haveand fails to have adequate“adequate directions for use [502(f)]. ” Labeling Requirements Labeling Requirements ?