is being presented by Dr. Gail E. Radcliffe, President, of Radcliffe Consulting and airs on Tuesday, September 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.
