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U.S. FDA Radiation-Emitting Electronic Device Reporting

U.S. FDA CITATION: 21 C.F.R. § 1002 (2016)

The U.S. Food and Drug Administration (FDA) requires most manufacturers, importers, and assemblers of Radiation-Emitting Electronic Devices (RED) to submit a report to FDA to obtain a FDA Accession Number for each device before marketing the device in the USA. FDA further requires that annual reports be submitted by September 1st of each year.

Whether or not reporting is required, all manufacturers of Radiation-Emitting Electronic Devices located outside of the United States are required to designate an Agent for Service of Process.

Examples of common RED products include (but are not limited to):

  • Laser Devices (Surveying, laser leveling, laser alignment, laser cutting tools, laser pointers, etc.)
  • X-Ray Systems (Cabinet X-Ray systems, closed X-Ray systems, etc.)
  • Lamps (Metal halide lamps, mercury vapor lamps, etc.)
  • Light Emitting Diodes (LEDs), Intense Pulsed Lights (IPLs), etc.
  • Liquid Crystal Display (LCD) Monitors, LCD projectors, etc.
  • Ultrasonic Devices (Humidifier, jewelry cleaner, etc.)

Registrar Corp assists companies with FDA compliance. Complete the form below: