• CDRH Finalizes Policy Intended to Help Device Industry Reduce Regulatory Uncertainty

    A new standard operating procedure (SOP) unveiled last week by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) establishes how the agency plans to implement and update certain types of guidance documents. Background Guidance documents are commonly used by FDA to indicate its specific interpretation of otherwise vague statutory requirements. While they almost never establish legally enforceable standards (though they can, suc...