• CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

    The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices. The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , "is intended to provide greater clarity on FDA's decision making process," FDA wrote. According to the guidance document, "this guidance sets o...
  • Consumers Groups Attack FDA Over De Novo Process

    A group of 12 consumer groups is chastising the US Food and Drug Administration (FDA) for approving what they perceive to be 'high-risk' medical devices through FDA's de novo approval pathway . In a letter to FDA Commissioner Margaret Hamburg sent 29 February, the groups, including Consumers Union and Public Citizen, said that FDA's use of the de novo pathway was setting a bad precedent. "Medical devices intended to save lives should require FDA's most rigorous saf...
  • McCain, Casey Introduce Bill to Remove Medical Device Regulations

    Sens. John McCain (R-AZ) and Bob Casey (D-PA) introduced legislation on 3 February that would remove certain regulations that the senators believe is hurting medical device manufacturers and "streamline the pathway" that manufacturers use to bring their innovative products to market. Their bill, the Safe, Efficient, and Transparent Medical Device Approval Act (SET Device Act) (S. 2067) , would require the US Food and Drug Administration (FDA) to modify the de novo a...