Radiation-Emitting Products

Inspection of Facilities with Provisional Reinstatement of Certification

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Initially, DMQS gave priority to inspecting fully certified facilities. This is because provisionally certified facilities would be undergoing accreditation and associated corrective action with their accreditation body. Provisional facilities failing accreditation were required to close.

Since our initial inspection priority determination, the question has arisen as to whether reinstated facilities, although provisionally certified, should have a higher priority for inspection since they have failed accreditation at least once. After discussion, the FDA has determined that provisionally reinstated facilities should have the same priority for inspection as fully-certified facilities since there is evidence that they were not practicing high enough quality mammography to pass previous accreditation.

Page Last Updated: 07/25/2014
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