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  • Regulatory NewsRegulatory News

    FDA Modifies List of Standards for Premarket Device Reviews

    The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements. Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requ...
  • Dozens of Medical Device Standards Adopted, Re-Affirmed by FDA

    The US Food and Drug Administration (FDA) has released a new Federal Register notice indicating the modification of 116 medical device standards recognized by the agency, as well as 38 new device standards now recognized. The oft-updated List of Recognized Standards is generally updated anywhere between one and three times per year, and was last updated in August 2012 and before that in March 2012. It was created under the FDA Modernization Act of 1997, which gav...
  • FDA Approves 32 New Medical Device Standards

    The US Food and Drug Administration (FDA) has announced the adoption of a number of new international standards to guide the development and regulatory review of some medical devices. The standards, collected within FDA's List of Recognized Standards , are used by FDA during the premarket review of some products and allow a company or product to claim conformity to the standards to satisfy certain components of the review process. The FDA Amendments Act of 2007...