Monday, October 4, 1999
WASHINGTON - FDA has announced that it will create a new advisory panel to consider marketing applications for genetic tests. The Molecular and Clinical Genetics Panel (MCGP) of the Medical Devices Advisory Committee will be asked to "review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation," according to FDA.
The new panel also will provide advice on the product testing protocols and the design of clinical studies of genetic tests, according to Steve Gutman, director of the division of clinical laboratory devices at the Center for Devices and Radiological Health (CDRH). It will not be asked to render decisions about the social or ethical consequences of genetic tests, he said.