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All site change supplements should clearly identify any changes to manufacturing locations and associated changes to the manufacturing process that result.
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The system gives a significant reduction in sample sizes, blood-based interferences and allergen lot variabilities while offering improved accuracy. Read More
For reclassification proceedings based on new information and proceedings calling for PMAs for a pre-FDASIA class II device, the agency must convene a classification panel and obtain panel recommendations.
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AdvaMed CEO Scott Whitaker called the tax “bad health policy and bad economic policy,” and praised the committee for including the 5-year extension of the moratorium. Read More