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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What is FDA’s FFDM review process?

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Upon receipt of the completed FFDM package, FDA will review the documentation. If the application is complete and satisfactory, FDA grants an approval to the facility and sends a Letter of Acceptance. For an incomplete or unsatisfactory application, FDA will send a Letter of Denial or request additional information from the facility. FDA will then work with the facility and/or the medical physicist to resolve discrepancies and complete the application process.

 

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