2015 AACC

A Discussion of the New LDT Guidance-35206 (Room Georgia World Congress Center - Thomas Murphy Ballroom)

30 Jul 15
11:30 AM - 2:00 PM

Tracks: Government/Regulatory, Guidelines, Lab Management, Quality Assurance, Testing Methods

Speaker(s): James Nichols, Professor, Department of Pathology, Microbiology and Immunology, Medical Director of Clinical, Vanderbilt University School of Medicine; Alberto Gutierrez, FDA/CDRH; Andrew Fish, AdvaMedDx

Moderator(s): Vince Stine, AACC;

After this session, participants will be able to: 1) describe the FDA guidance on LDTs; 2) explain the views of industry and clinical laboratories; and 3) define potential impact of the guidance on their laboratory.