Last September, the U.S. Food and Drug Administration (FDA) released a draft guidance outlining how the agency intends to regulate IVDMIAs. These new, highly complex tests are increasingly being used to diagnose, treat and manage a variety of diseases and conditions, including breast and prostate cancer, as well as cardiovascular disease. Since IVDMIAs
are performed largely in-house, many laboratories assumed they were not subject to the FDA oversight—however, they were wrong.
This controversial new guidance has created confusion within the laboratory community about which in-house developed tests are subject to FDA oversight and which are not. Further, concerns have been raised by some in the laboratory community regarding the potential impact this new policy may have on innovation and access to newer technologies. Join AACC/ASCLS for a frank and lively discussion with the FDA where you will hear their perspective on these issues. Participants will also get an in-depth assessment from a long-time laboratory director regarding the pluses and minuses associated with this new policy.
Participate in this audioconference and learn:
- The intent and scope of the new IVDMIA guidance
- FDA’s current policy regarding in-house developed tests
- How the agency is implementing this policy
- What labs need to do to comply
- What impact it will have on clinical laboratories
AACC designates this program for a maximum of 1.5 ACCENT credit hours toward the AACC Clinical Chemist’s Recognition Award. Register today to learn the latest on IVD Multivariate Index Assays (MIAs).
To register for this conference, or to get more information, visit http://www.aacc.org/aacc/events/meetings/meetingdetail.htm?ID=4264&PH=Conference. |
