Advisory Committees

Microbiology Devices Panel

March 8, 2019 Panel Meeting

FDA plans to hold a meeting of the Microbiology Devices Panel on March 8, 2019 to discuss and make recommendations regarding new or alternative approaches to the development and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid. Topics to be addressed include clinical study design, comparator methods, and device indications for use. The FDA is seeking expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics. 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)
Aden Asefa
301-796-0400

Page Last Updated: 11/19/2018
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