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Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
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Subpart
A
General Provisions
Subpart
B
Procedures for Device Establishments
Subpart
C
Procedures for Foreign Device Establishments
Subpart
D
Exemptions
Subpart
E
Premarket Notification Procedures