FDA环氧乙烷灭菌设施 III 类设备变更的过渡性执法政策_中英文版

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Contains Nonbinding Recommendations

Transitional Enforcement Policy for

Ethylene Oxide Sterilization Facility

Changes for Class III Devices

Guidance for Industry and

Food and Drug Administration Staff

Document issued on November 26, 2024.

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

SiteChange@fda.hhs.gov.

For questions about this document regarding CBER-regulated devices, contact

ocod@fda.hhs.gov.

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

III类器械环氧乙烷灭菌装置变更的

过渡性执行政策

行业指南和FDA工作人员指南

文件发布于2024年11月26日。

SiteChange@fda.hhs.gov如需了解本文件中与 CDRH 监管器械相关的问题，请联系 CDRH -ETO- 。

ocod@fda.hhs.gov如需了解本文件中关于CBER监管器械的问题，请联系。

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

Preface

Public Comment

You may submit electronic comments and suggestions at any time for Agency consideration 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 FDA-2024-D-2274. Comments may not be

acted upon by the Agency until the document is next revised or updated.

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

GUI00007027 and complete title of the guidance in the request.

CBER

Additional copies of this guidance are available from the Office of Communication, Outreach

and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,

MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or

from the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-

regulatory-information-biologics.

For questions on the content of this guidance, contact OCOD at the phone numbers or email

address listed above.

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标签： #环氧乙烷 #中文 #环氧乙烷灭菌

摘要：

ContainsNonbindingRecommendationsTransitionalEnforcementPolicyforEthyleneOxideSterilizationFacilityChangesforClassIIIDevicesGuidanceforIndustryandFoodandDrugAdministrationStaffDocumentissuedonNovember26,2024.ForquestionsaboutthisdocumentregardingCDRH-regulateddevices,contactCDRH-ETO-SiteChange@fda.h...

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FDA环氧乙烷灭菌设施 III 类设备变更的过渡性执法政策_中英文版

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