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  • FDA Re-Recognizes Three Radiology Consensus Standards

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards. Background Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses ...
  • 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...
  • Feature ArticlesFeature Articles

    New Medical Device Standard Puts Healthcare at Risk

    One of the greatest challenges in discussing standards is trying to put things into context so all those affected can understand why they matter. To illustrate this, I want to start with a simple picture- a snapshot of a remarkable moment in time. It shows how small medical device companies can make major contributions to healthcare, and but also how one standard is threatening to undo these gains. [media:1248:embed:{800}:{500}] This photograph was taken in Brazil ...
  • New ISO/IEC Guide Addresses Medical Device Safety Regulations

    A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards. ISO/IEC Guide 63:2012,  Guide to the development and inclusion of safety aspects in international standards for medical devices , seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of...