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U.S. FDA Radiation-Emitting Electronic Device Labeling Requirements

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To learn how this service would be helpful for your particular Radiation-Emitting Electronic Device label, simply complete the form below:

  I want to verify that my labeling meets current U.S. FDA requirements.
  I have a shipment detained due to labeling violations and need immediate assistance.
  I have not yet designed my product labeling and would like assistance.
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Type of Business (Select all that apply): *
Manufacturer - Owns or operates a facility that manufactures a Radiation-Emitting Electronic Device. This term includes contract manufacturers, contract packers, "private" labelers, and other entities that manufacture or import a Radiation-Emitting Electronic Device.
Importer - Engaged in importing a Radiation-Emitting Electronic Device into United States.
Distributor - Engaged in distributing a Radiation-Emitting Electronic Device.
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U.S. FDA Regulations:

U.S. FDA Radiation-Emitting Electronic Device Performance Requirements: 21 C.F.R. Part 1010 et seq.

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