Radiation-Emitting Products

Now that FDA has approved FFDM accreditation bodies, do we have to have our FFDM unit accredited?

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If your State accreditation body or ACR has received FDA approval to accredit your specific model FFDM unit, then you must have your unit accredited by one of those bodies. If neither your State accreditation body nor ACR has received FDA approval to accredit your specific model FFDM unit, then you need to have FDA extend your facility's certification to cover your FFDM unit before you can use it clinically.

 

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Page Last Updated: 08/07/2014
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