FDA：磁共振(MR)环境中医疗器械安全性的测试与标签_中英文版

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Contains Nonbinding Recommendations

Testing and Labeling Medical

Devices for Safety in the Magnetic

Resonance (MR) Environment

Guidance for Industry and Food and

Drug Administration Staff

Document issued on October 10, 2023.

Document originally issued on May 20, 2021

For questions about this document, contact the Office of Science & Engineering Laboratories

(OSEL), OSEL_CDRH@fda.hhs.gov, (301) 796-2530.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

包含无约束力的建议

磁共振（MR）环境中医疗器械

安全性的测试和标签

行业指南和FDA工作人员指南

文件发布于2023年10月10日。

文件最初发布于2021年5月20日

OSEL_CDRH@fda.hhs.gov

如对本文件有疑问，请联系科学与工程实验室办公室（OSEL），，电

话：（301）796-2530。

美国卫生与公众服务部食品和药物管理局

器械与放射卫生中心

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-2019-D-2837. Comments

may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to

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

number GUI01500059 and the complete title of the guidance in the request.

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标签： #医疗器械 #环境 #FDA

摘要：

ContainsNonbindingRecommendationsTestingandLabelingMedicalDevicesforSafetyintheMagneticResonance(MR)EnvironmentGuidanceforIndustryandFoodandDrugAdministrationStaffDocumentissuedonOctober10,2023.DocumentoriginallyissuedonMay20,2021Forquestionsaboutthisdocument,contacttheOfficeofScience&EngineeringLab...

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FDA：磁共振(MR)环境中医疗器械安全性的测试与标签_中英文版

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