Radiation-Emitting Products

Under the Certification Extension Program, does a facility wishing to add a CR system to a screen film (S-F) unit need to keep accreditation for an existing unit?

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Yes, the facility will need to maintain accreditation with an FDA-approved accreditation body (AB) for at least one unit other than the CR system. This means the facility must either keep accreditation for the S-F unit, with which the CR system shares the cassette holder, or another S-F unit or an FFDM unit. Once the FDA approves an AB to accredit your specific CR system, the facility will have to apply to that AB for accreditation of the CR system. Once it gets accreditation from the AB for the CR system, the facility will not need to maintain the additional accreditation unless it wishes to continue using the other units. Note: Your facility is also required to undergo an annual onsite MQSA inspection of the CR unit(s) during the inspection of S-F and/or FFDM accredited unit(s) (section 354 of the MQSA).

 

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Page Last Updated: 08/11/2014
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