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  • 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...