Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device
FDA Law Blog
APRIL 19, 2021
The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products. As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval.
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