FDA Medical Devices
Image credit: Piqsels

FDA Medical Device Regulations: What You Should Know

Class I Medical Devices

Class I FDA Devices
Image credit: Piqsels

Class II Medical Devices

Class III Medical Devices

FDA Medical Device Good Manufacturing Practices

Labeling Requirements for FDA Medical Devices

  • The manufacturer’s name and business location
  • The dosage quantity
  • The frequency and duration of use
  • When to use the device
  • Directions for how to administer or apply the device
  • Any preparation steps necessary for using the device
  • The device’s intended use

510(k) Premarket Notification

Premarket Approval Application

FDA Incident Reports: Requirements for Manufacturers, Importers, and Medical Facilities

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