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FDA Roundtable Print E-mail
ASM hosted an FDA Roundtable meeting on 8 October for laboratory stakeholders. Speakers included Alberto Gutierrez, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA Center for Devices and Radiological Health (CDRH), and Karen Bijwaard, also of CDRH. Gutierrez discussed updates to laboratory-developed test regulations and the CDRH Plan of Action for the 510(k) program, and Bijwaard discussed changes in RUO/IUO marketing practices and In Vitro Companion Diagnostics guidance. Some of the organizations represented at the roundtable were the American Association for Clinical Chemistry (AACC), the American Clinical Laboratory Association (ACLA), the American Society for Clinical Laboratory Science (ASCLS), the American Society for Clinical Pathology (ASCP), the Association for Molecular Pathology (AMP), the American Medical Technologists (AMT), the Association of Public Health Laboratories (APHL), and the College of American Pathologists (CAP). More information about the changes to the above-mentioned topics can be found on the CDRH website at http://www.fda.gov/About FDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm.
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