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FDA Microbiology Devices Panel Advisory Committee: HPV Diagnostics

March 8, 2019 @ 8:00 am - 5:00 pm EST

A public advisory committee meeting of the FDA’s Microbiology Devices Panel be held on March 8, 2019 in Gaithersburg, Maryland.

The committee will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid.

Topics to be addressed at the meeting include clinical study design and comparator methods. Additionally, the committee will discuss potential changes to the High Risk HPV device indications for use considering continually evolving cervical cancer screening guidelines. The committee will provide expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics and make recommendations for future High Risk HPV device evaluation strategies that are both scientifically rigorous and least burdensome.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 1, 2019. Oral presentations from the public will be scheduled on March 8, 2019, between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 21, 2019.

For further information please contact Aden Asefa, Center for Devices and Radiological Health,, 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138.


March 8, 2019
8:00 am - 5:00 pm EST


Food and Drug Administration (FDA)
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Hilton Washington DC North Gaithersburg
620 Perry Pkwy
Gaithersburg, MD 20877 United States
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(301) 977-8900