The U.S. Food and Drug Administration has turned down an appeal from breast technology developer Biofield that would have made it easier for the Atlanta-based company to get its flagship product through the regulatory approval process.
Biofield had asked the FDA to reclassify its Biofield Breast Proliferation Rate Detection System (BDS) from a class III device, which requires a premarket approval (PMA) application, to a class I or class II device, which can go through the less rigorous 510(k) process.
The FDA rejected the petition, however, ruling that BDS should be treated as a class III device that requires a PMA submission. Biofield said it intended to move forward with the regulatory submission under the PMA process, and would be discussing data requirements with the FDA shortly.
BDS measures electrical activity in the breast to detect epithelial cancers, including breast cancer. The company believes the device can be a useful adjunct to mammography, ultrasound, and other technologies in helping to reduce surgical biopsies on suspicious breast lesions.
By AuntMinnie.com staff writers
March 9, 2005
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Biofield makes regulatory progress on BDS, November 16, 2004
Biofield nets African distribution deal, December 7, 2001
Biofield to try again with FDA, September 18, 2001
Biofield begins Europe survey, August 31, 2000
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