Radiation-Emitting Products

What inspection costs are associated with CR certification?

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FDA will treat an S-F unit that is equipped with a CR system as two separate units (one S-F; one FFDM). Therefore, inspectors will inspect a single physical unit that is used to perform S-F mammography and CR mammography as two separate units, and FDA will bill the facility for two units. Once FDA approves an accreditation body to accredit the specific CR system used by the facility, the facility may begin the accreditation process for the CR unit and drop the S-F accreditation, thereby reducing their unit inspection and accreditation costs.

 

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Page Last Updated: 08/12/2014
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