题库 医学 题目列表 An IVD has the same intended use as a predicate bu...
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An IVD has the same intended use as a predicate but uses a different technology. It may still qualify for 510(k) if:

A.

The technology is cheaper

B.

The differences do not raise different questions of safety and effectiveness

C.

The sponsor submits no performance data

D.

The device is sold only online

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