FDA 510(k) Third Party Review Program Industry, Food and Drug Administration Staff, and Third Party Review Organizations
标准简介
510(k) Third Party Review Program Industry, Food and Drug Administration Staff, and Third Party Review Organizations[附网盘链接]是Food&Drug Administration于当前发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为510(k) Third Party Review Program Industry, Food and Drug Administration Staff, and Third Party Review Organizations[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
510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations 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 The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) 1
Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. FDA’s implementation of section 523 establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P510k Review Program within the Center for Devices and Radiological 2
Health (CDRH). This guidance document also reflects amendments made to section 523 by the 3 4
FDA Reauthorization Act of 2017 (FDARA), which directed FDA to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. For the current edition of the FDA-recognized standards referenced in this document, see the 5
FDA Recognized Consensus Standards Database. For more information regarding use of 1
Section 523 of the FD&C Act uses the terms “accredited persons,” “accredit,” “accredited,” “accreditation,” “reaccredit,” “reaccredited,” and “reaccreditation.” The guidance does not use those statutory terms but rather defines such terms as “recognition,” and “rerecognition” as synonymous terms. These alternative terms are used in this guidance to harmonize the terms used by FDA and in the FD&C Act with those in the International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) documents and are defined in Section IV of this guidance. 2
Currently, the Center for Biologics Evaluation and Research does not regulate devices of the types subject to this guidance. 3
Pub. L. 115-52 4
See section 523(a)(3)(B) of the FD&C Act. 5
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
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