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Guide to Medical Device Regulation, December 2025

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Quick Links

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Tab 100 - Overview of FDA Device Regulation
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Tab 200 - FDA Jurisdiction Over Devices
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Tab 300 - Registration, Listing, and Labeling Requirements
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Tab 400 - Classification and Reclassification
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Tab 500 - Investigational Device Exemption — IDE
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Tab 600 - Quality Systems
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Tab 700 - Premarket Approval — PMA
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Tab 800 - Premarket Notification — 510(k)
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Tab 900 - Reporting and Tracking Requirements
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Tab 1000 - Exports and Imports
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Tab 1100 - Enforcement
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Tab 1200 - FDA Device Regulation’s Relationship with Other Federal Authorities
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Tab 1300 - State Regulations and Preemption

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