Several FDA advisory committees are meeting before the year is out to discuss and make recommendations on a variety of products and issues. The meetings concerning medical devices are listed below:
RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Sept. 24, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Shanika Craig, 301-796-6639
The committee will discuss, make recommendations and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic Inc (HOLX.O). The Selenia C Digital Breast Tomosynthesis System is intended for use in the same clinical applications as traditional mammographic systems.
GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov. 18, 0800/1300
LOCATION: Holiday Inn, 10000 Baltimore Ave., College Park, Md.
CONTACT: Margaret McCabe-Janicki, 301-796-7029
The committee will discuss, make recommendations and vote on MELA Sciences Inc's MelaFind. The device is a computer-controlled multispectral dermoscope that uses light to image the skin through a thin layer of liquid (alcohol or oil). A complementary metal oxide semiconductor digital camera inside the probe captures the images and then differentiates them among pigmented skin lesions for melanoma risk using predefined software statistical pattern recognition algorithms.
DENTAL PRODUCTS PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Dec 14-15, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Olga Claudio, 301-796-7608
The committee will discuss and make recommendations on scientific issues raised in petitions received by FDA concerning the final rule on the classification of dental amalgam, which published in the Federal Register on August 4, 2009. Issues raised in the petitions include the adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on risk assessments issued by the National Academy of Sciences, entitled "Science and Decisions: Advancing Risk Assessment," NAP, 2009.