FDA/Industry IVD Roundtables
All presentations are combined into a single zip drive.
Please email AMDM if you have any difficulty downloading the package
Background
The IVD roundtable is a group of FDA and In Vitro Diagnostic Device Industry trade association representatives whose mission is to improve 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 agency to foster and maintain consistent and dynamic lines of communication with regulated industry, professional organizations, and academia is greater than ever before.
Established in 1973, the Association of Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade association 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 cell cultures and cell culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology assays.
November 2018 FDA/Industry IVD Roundtable Agenda
November 2018 FDA/Industry IVD Roundtable Presentations
May 2018 FDA/Industry IVD Roundtable Agenda
May 2018 FDA/Industry IVD Roundtable Presentations
November 2017 FDA/Industry IVD Roundtable Agenda
November 2017 FDA/Industry IVD Roundtable Presentations
December 2016 FDA/Industry IVD Roundtable Agenda
December 2016 FDA/Industry IVD Roundtable Presentations
June 2016 FDA/Industry IVD Roundtable Agenda
June 2016 FDA/Industry IVD Roundtable Presentations
November 2015 FDA/Industry IVD Roundtable Agenda
November 2015 FDA/Industry Roundtable Presentations
November 2014 FDA/Industry IVD Roundtable Agenda
November 2014 FDA/Industry Roundtable Presentations
May 2014 FDA/Industry IVD Roundtable Agenda
May 2014 FDA/Industry IVD Roundtable Presentations
November 2013 FDA/Industry IVD Roundtable Agenda
November 2013 FDA/Industry IVD Roundtable Presentations
May 2013 FDA/Industry IVD Roundtable Agenda
May 2013 FDA/Industry IVD Roundtable Presentations
November 2012 FDA/Industry IVD Roundtable Agenda
November 2012 FDA/Industry IVD Roundtable Presentations
June 2012 FDA/Industry IVD Roundtable Agenda
June 2012 FDA/Industry IVD Roundtable Presentations
December 2011 FDA/Industry IVD Roundtable Agenda
December 2011 FDA/Industry IVD Roundtable Presentations
June 2011 FDA/Industry IVD Roundtable Agenda
June 2011 FDA/Industry IVD Roundtable Presentations
FDA-Industry IVD Roundtable Meeting -- August 12, 2010
FDA-Industry IVD Roundtable Meeting -- January 13, 2010
May 2018 FDA/Industry IVD Roundtable Presentations
November 2017 FDA/Industry IVD Roundtable Agenda
November 2017 FDA/Industry IVD Roundtable Presentations
December 2016 FDA/Industry IVD Roundtable Agenda
December 2016 FDA/Industry IVD Roundtable Presentations
June 2016 FDA/Industry IVD Roundtable Agenda
June 2016 FDA/Industry IVD Roundtable Presentations
November 2015 FDA/Industry IVD Roundtable Agenda
November 2015 FDA/Industry Roundtable Presentations
November 2014 FDA/Industry IVD Roundtable Agenda
November 2014 FDA/Industry Roundtable Presentations
May 2014 FDA/Industry IVD Roundtable Agenda
May 2014 FDA/Industry IVD Roundtable Presentations
November 2013 FDA/Industry IVD Roundtable Agenda
November 2013 FDA/Industry IVD Roundtable Presentations
May 2013 FDA/Industry IVD Roundtable Agenda
May 2013 FDA/Industry IVD Roundtable Presentations
November 2012 FDA/Industry IVD Roundtable Agenda
November 2012 FDA/Industry IVD Roundtable Presentations
June 2012 FDA/Industry IVD Roundtable Agenda
June 2012 FDA/Industry IVD Roundtable Presentations
December 2011 FDA/Industry IVD Roundtable Agenda
December 2011 FDA/Industry IVD Roundtable Presentations
June 2011 FDA/Industry IVD Roundtable Agenda
June 2011 FDA/Industry IVD Roundtable Presentations
FDA-Industry IVD Roundtable Meeting -- August 12, 2010
FDA-Industry IVD Roundtable Meeting -- January 13, 2010