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Medical Devices
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Standards (Medical Devices)
Standards Program
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How to use this program
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Guidance
- Frequently Asked Questions on Recognition of Consensus Standards
- Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards
- Guidance for Industry and for FDA Staff: Use of Standards in Substantial Equivalence Determinations
- CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition
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