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Health / Premarket approval / Medical device / Investigational Device Exemption / Center for Devices and Radiological Health / Design controls / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Title 21 CFR Part 11 / Food and Drug Administration / Medicine / Technology


http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H
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