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Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document
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Appropriate use of voluntary is a program that allows individuals or organizations to self-report non-compliance with regulations.
Any individual or organization that has violated regulations and wishes to correct the violation voluntarily.
You can fill out appropriate use of voluntary by providing details of the violation, steps taken to correct it, and measures put in place to prevent future violations.
The purpose of appropriate use of voluntary is to encourage voluntary compliance with regulations and to reduce penalties for violations.
Information such as details of the violation, corrective actions taken, and preventive measures implemented must be reported on appropriate use of voluntary.
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