 |
|
|
|||||||||||
In Vitro Diagnostic Multivariate Program Overview:
The Food and Drug Administration (FDA) recently released revised draft guidance on "In Vitro Diagnostic Multivariate Index Assays". The initial IVDMIA draft guidance met with considerable interest from the laboratory community and others. Stakeholders were concerned that the definition of IVDMIAs in the initial draft guidance document could encompass a wider range of tests than FDA had intended, they raised questions about the FDA regulatory mechanisms in general, such as how devices are classified and reviewed based on the risk of the intended use; how laboratory-developed IVDMIAs should be labeled; and how manufacturers can update and improve cleared or approved devices using existing mechanisms within the regulatory framework. There was a general concern that requiring FDA regulatory compliance for IVDMIAs has the potential to discourage the development of new tests for rare diseases and could stifle the innovation of new tests to the market. This ACLA LABline program will provide expert insight into FDA’s revised thinking on IVDMIAs. You will learn from a leading agency expert how FDA has revised the guidance document to address the issues raised and more. How it Works: It’s easy. Sign-up using the Online registration form or download the form and fill out as needed. The registration fee entitles each site to one phone line with as many participants at the site as interested. So please, share this information packed program with your colleagues. Prior to the audio conference, we will provide you with instructions on how to sign-in and participate. 5 Ways to Register:
|
|||||||||||
© Copyright 2004–2006 American Clinical Laboratory Association. All rights reserved. Site design by OmniStudio |