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Roundtables - Association of Medical Diagnostics Manufacturers

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Roundtables -Undertoneof Medical Diagnostics Manufacturers About Board Scholarships Members Join 2018 Focus Meeting Education Roundtables Past Presentations RA/QA Topics Links Networking Jobs Contact StoreUndertoneof Medical Diagnostics Manufacturers FDA/Industry IVD RoundtablesAll presentations are combined into a single zip drive. ​Please email AMDM if you have any difficulty downloading the packageBackgroundThe IVD roundtable is a group of FDA and In Vitro Diagnostic Device Industry trade undertone representatives whose mission is to modernize communications between FDA and the regulated industry.  In its meetings held quarterly since 1995, the Roundtable members have identified areas where improved communications could have substantial benefits for both parties.  The Roundtable provides a forum for successfully addressing difficult policy and scientific issues related to the regulation of IVDs.  In a period of policy development, rapid technological advancements, as well as congressional mandates, the need for the organ to foster and maintain resulting and dynamic lines of liaison with regulated industry, professional organizations, and academia is greater than overly before. Established in 1973, theUndertoneof Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade undertone that serves as a resource for education and information on compliance issues between member companies, and as an interface between member companies and the FDA.  Today membership includes companies of all sizes who manufacture and distribute in vitro diagnostic products, including lamina cultures and lamina culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology assays.  ​ May 2018 FDA/Industry IVD  Roundtable AgendaMay 2018 FDA/Industry IVD  Roundtable Presentations​November 2017 FDA/Industry IVD Roundtable AgendaNovember 2017 FDA/Industry IVD Roundtable PresentationsDecember 2016 FDA/Industry IVD Roundtable AgendaDecember 2016 FDA/Industry IVD Roundtable PresentationsJune 2016 FDA/Industry IVD Roundtable AgendaJune 2016 FDA/Industry IVD Roundtable Presentations​November 2015 FDA/Industry IVD Roundtable AgendaNovember 2015 FDA/Industry Roundtable Presentations​November 2014 FDA/Industry IVD Roundtable AgendaNovember 2014 FDA/Industry Roundtable PresentationsMay 2014 FDA/Industry IVD Roundtable AgendaMay 2014 FDA/Industry IVD Roundtable PresentationsNovember 2013 FDA/Industry IVD Roundtable AgendaNovember 2013 FDA/Industry IVD Roundtable PresentationsMay 2013 FDA/Industry IVD Roundtable AgendaMay 2013 FDA/Industry IVD Roundtable PresentationsNovember 2012 FDA/Industry IVD Roundtable AgendaNovember 2012 FDA/Industry IVD Roundtable PresentationsJune 2012 FDA/Industry IVD Roundtable AgendaJune 2012 FDA/Industry IVD Roundtable PresentationsDecember 2011 FDA/Industry IVD Roundtable AgendaDecember 2011 FDA/Industry IVD Roundtable PresentationsJune 2011 FDA/Industry IVD Roundtable AgendaJune 2011 FDA/Industry IVD Roundtable PresentationsFDA-Industry  IVD Roundtable Meeting -- August 12, 2010FDA-Industry  IVD Roundtable Meeting  -- January 13, 2010 Copyright © 2011 AMDM, 555 Thirteenth Street, NW Washington, D.C. 20004 Contact   About   Join   Store   Privacy Policy