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What You Need to Know About the FDA’s Push to Regulate Laboratory …Bio-IT WorldThe FDA has regulated these commercial in vitro diagnostics since 1976, when Congress passed the Medical Device Amendments (MDA) making clear that these tests fall under the definition of a “medical device” subject to FDA authority. Some tests, however …and more »…What You Need to Know About the FDA’s Push to Regulate Laboratory … – Bio-IT World
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