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器械和辐射健康中心: FDA合格评定计划联邦注册公告
作者:FDA 【阅读原文】

CDRH Industry: FR Notice (Request for Comments) on FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

Today, the U.S. Food and Drug Administration issued a Federal Register Notice establishing a public docket for comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The purpose is to gain insight regarding the development and overall design/approach of the ASCA pilot program including goals, standards, and design concepts.

Please submit electronic or written comments or information to this notice by 45 days after date of publication in the Federal Register.

For more information, please see the FDA’s Medical Device User Fee Amendments 2017 (MDUFA IV).

The FDA regularly updates the list of national and international voluntary consensus standards recognized for use in satisfying portions of device premarket review submissions or other requirements.  If you have any questions about these standards, please contact the CDRH Standards Program at Standards@cdrh.fda.gov.

Thank you.

Center for Devices and Radiological Health
Food and Drug Administration

 

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