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
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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ContainsNonbindingRecommendationsTransitionalEnforcementPolicyforEthyleneOxideSterilizationFacilityChangesforClassIIIDevicesGuidanceforIndustryandFoodandDrugAdministrationStaffDocumentissuedonNovember26,2024.ForquestionsaboutthisdocumentregardingCDRH-regulateddevices,contactCDRH-ETO-SiteChange@fda.h...
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作者：薛定谔的龙猫
分类：专业资料
价格：80质量币
属性：42 页
大小：1.13MB
格式：PDF
时间：2025-11-12
