• Regulatory NewsRegulatory News

    FDA Puts Major Restrictions on Power Morcellators Following Cancer Concerns

    US regulators today announced major restrictions on laparoscopic power morcellator (LPM) devices following major concerns that the devices could be harming patients. Background The restrictions, announced on 24 November 2014 by the US Food and Drug Administration (FDA), follow months of major concern that the devices could be harming women more than they helped. Power morcellators were primarily used to remove non-cancerous uterine fibroids by morcellating the tissue ...
  • 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...