FDA c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)
标准简介
c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)[附网盘链接]是FDA于不久前发布的FDA标准，适用于United States。标准截图
![c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)[附网盘链接]](/img/20210914103604nbouk.jpg)
标准文档说明
标准文档类型为c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot). The ASCA Pilot is described in FDA’s 1
guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. For the edition of the FDA-recognized consensus standard(s) included in the ASCA Pilot, see 2
the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA’s guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 3
Devices and Standards Development and the Use of Standards in Regulatory Submissions 4
Reviewed in the Center for Biologics Evaluation and Research. 1
Available at: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 2
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 3
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 4
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-
development-and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation
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