November 9, 2016 Panel Meeting
FDA plans to hold a two-day meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee on November 9, 2016, to discuss and make recommendations regarding transplant-associated opportunistic viral infections. Topics to be the addressed include reclassification of quantitative CMV viral load devices from Class III (Premarket approval) to Class II (510(k)), and appropriate initial classification for quantitative viral load devices for EBV, BK, JCV, HHV6, and Adenovirus infections. The FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation. This meeting will be announced in the Federal Register to provide further details.
November 10, 2016 Panel Meeting
FDA plans to hold a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee on November 10, 2016, to discuss and make recommendations regarding the use of procalcitonin (PCT) as an aid in the management of patients with suspected lower respiratory tract infection (LRTI). Specific issues to be discussed include the use of PCT to differentiate bacterial infection from other acute respiratory disorders and for monitoring response to antibiotic therapy in patients being treated for bacterial pneumonia. This meeting will be announced in the Federal Register to provide further details.
The Microbiology Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes appropriate recommendations to the Commissioner of Food and Drugs.
Designated Federal Officer (DFO)