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HomeU.S. FDA Radiation-Emitting Electronic Device Regulations › Reporting Requirements

U.S. FDA Radiation-Emitting Electronic Device Requirements

The U.S. Food and Drug Administration (FDA) requires most manufacturers, dealers, and distributors 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, leveling, alignment, laser cutting tools, laser pointers, etc.)
  • X-Ray Systems
  • Lamps (Metal halide lamps, mercury vapor lamps, etc.)

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

 Obtain an Accession Number for a new Radiation-Emitting Electronic Device
 Obtain an Accession Number for a Supplemental or Annual Report
 Convert a paper Radiation-Emitting Electronic Device Report to FDA's Electronic System
 Change your Agent for Service of Process
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U.S. FDA Regulations:

U.S. FDA Radiation-Emitting Electronic Device Reporting:
21 C.F.R. Part 1002 et seq.


 


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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