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Product Safety Requirements Applicable to Medical Devices (US)

Medical Device Listing

Manufacturers must register their devices with the FDA. Establishments required to list their devices include:

  • Manufacturers
  • Contract manufacturers that commercially distribute the device
  • Contract sterilizers that commercially distribute the device
  • Re-packagers and re-labelers
  • Specification developers
  • Re-processors single-use devices
  • Remanufacturer
  • Manufacturers of accessories and components sold directly to the end user
  • U.S. manufacturers of “export only” devices

 

Medical Device Labeling Provisions

Per the FDA, the label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Additional FDA regulations regarding required labeling can be found on the FDA Device Labeling webpage.  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ucm2005422.htm

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