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    Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections

    As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications. The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(...