Roche ASR Marketing Approach For AmpliChip Microarray Draws FDA Scrutiny
CDRH is asserting that Roche's AmpliChip CYP450 microarray, launched June 25, does not qualify as an analyte-specific reagent, and may require premarket review
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The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.