特定上市前提交审查的质量管理体系信息-2025草案_中英文版

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Contains Nonbinding Recommendations

Draft – Not for Implementation

Quality Management System

Information for Certain Premarket

Submission Reviews

Draft Guidance for Industry and

Food and Drug Administration Staff

DRAFT GUIDANCE

This draft guidance document is being distributed for comment purposes

only.

October 2025

You should submit comments and suggestions regarding this draft document within 60 days of

publication in the Federal Register of the notice announcing the availability of the draft

guidance. Submit electronic comments to https://www.regulations.gov. Submit written

comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane,

Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the docket

number listed in the notice of availability that publishes in the Federal Register.

For questions about this document regarding CDRH-regulated devices, contact Office of

Regulatory Policy/Division of Submission Support at 301-796-5640 or

CDRHPremarketProgramOperations@fda.hhs.gov. For questions about this document regarding

CBER-regulated devices, contact the Office of Communication, Outreach and Development

(OCOD) at 800-835-4709 or 240-402-8010, or industry.biologics@fda.hhs.gov.

When final, this guidance will supersede “Quality System Information

for Certain Premarket Application Reviews,” issued February 3, 2003.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

包含无约束力的建议草案

不用于实施

某些上市前提交审查的质量管理体

系信息

行业和FDA工作人员的草案指南

草案指南

本指南草案仅供征求意见。

2025年10月

https://www.regulations.gov

您应在本指南草案公告于

《联邦公报》

发布之日起60日内提交意见和建议。电子

版意见请发送至，纸质版意见请寄至：美国食品药品

监督管理局档案管理处，地址：马里兰州罗克维尔市费舍斯巷5630号1061室（邮

编20852-1740），电话：（HFA-305）。所有意见请务必标注公告中公布的

《联

邦公报》

档案编号。

CDRHPremarketProgramOperations@fda.hhs.gov

industry.biologics@fda.hhs.gov

如需了解本文件中关于CDRH监管器械的问题，请联系监管政策办公室/提交支持部，电

话：301-796-5640或。如需了解本文件中

关于CBER 监管器械的问题，请联系通信、外联和发展办公室（OCOD），电话：

800-835-4709或240-402-8010，或。

最终，本指南将取代2003年2月3日发布的“某些上市前申请审查的质量体

系信息”。

美国卫生与公众服务部

美国食品药品监督管理局器械中

心与放射卫生中心生物制品评价与研究中心

Contains Nonbinding Recommendations

Draft – Not for Implementation

Preface

Additional Copies

CDRH

Additional copies are available from the Internet. You may also send an email request to

CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document

number GUI00001140 and complete title of the guidance in the request.

CBER

Additional copies are available from the Office of Communication, Outreach, and Development

(OCOD), Center for Biologics Evaluation and Research (CBER), by calling 800-835-4709 or

240-402-8010, by email, industry.biologics@fda.hhs.gov, or from the Internet at

https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-

biologics/biologics-guidances.

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标签： #管理 #质量管理体系 #质量管理

摘要：

ContainsNonbindingRecommendationsDraft–NotforImplementationQualityManagementSystemInformationforCertainPremarketSubmissionReviewsDraftGuidanceforIndustryandFoodandDrugAdministrationStaffDRAFTGUIDANCEThisdraftguidancedocumentisbeingdistributedforcommentpurposesonly.October2025Youshouldsubmitcommentsa...

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