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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Records and Reporting (Radiation-Emitting Products)

Reports of problems and hazards:

FDA eSubmitter Program:

The FDA eSubmitter program allows you to submit many Product Safety Reports and Annual Reports electronically. This free software is available for voluntary use by manufacturers in the Radiological Health industries. For more information about see FDA eSubmitter.

Required reports:

Variance requests:

Records to be maintained: