Advisory Committees

Microbiology Devices Panel

March 21-22, 2018 Panel Meeting

FDA plans to hold a two-day joint meeting of the CDRH Microbiology Devices Panel of the Medical Devices Advisory Committee and the CBER Blood Products Advisory Committee (BPAC) on March 21-22, 2018, to discuss and make recommendations regarding reclassification of diagnostic tests for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Topics to be addressed on March 21st include reclassification of point-of-care and laboratory-based serological and molecular tests for the diagnosis of HIV in patients from Class III (Premarket approval) to Class II (510(k)). Topics to be addressed on March 22nd include reclassification of serological and molecular tests for the diagnosis of HCV, HCV viral load tests, and HCV genotyping tests in patients from Class III (Premarket approval) to Class II (510(k)). The FDA is seeking expert recommendations to assess the potential risks and benefits of these devices if cleared under proposed Class II special controls. Devices for screening blood products for HCV or HIV are not being considered for reclassification and will not be discussed at the panel meeting. 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 diagnostic devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes recommendations to the Commissioner of Food and Drugs.

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)
Aden Asefa
301-796-0400

Page Last Updated: 03/29/2018
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