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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 March 11, 2016, Mix Biopharmaceuticals, Ltd Attention: Ms. Shikhar Goal Ethicon, Inc. P.O. Box 151 Route
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What is attention ms - fda?
Attention ms - fda stands for Medical Device Single Audit Program (MDSAP). It is a program that allows the audits of medical device manufacturers to be conducted by regulatory authorities in accordance with a single set of auditing criteria.
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Medical device manufacturers who want to market their products in certain countries that participate in the MDSAP program are required to file attention ms - fda.
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To fill out attention ms - fda, manufacturers need to provide detailed information about their quality management systems, manufacturing processes, and compliance with regulatory requirements.
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The purpose of attention ms - fda is to streamline the audit process for medical device manufacturers and ensure that their products meet regulatory requirements in multiple countries.
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Information that must be reported on attention ms - fda includes details about the manufacturer's quality management system, manufacturing processes, design controls, risk management, and post-market surveillance.
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