BIOFIELD RESPONDS TO FDA 'NONSUBSTANTIAL EQUIVALENCE' DETERMINATION

Biofield, developer of the Biofield Breast Proliferation Rate Detection System (BDS) -- a noninvasive, radiation-free adjunctive test system that may be of assistance in the evaluation of suspicious breast lesions -- has submitted a petition to the FDA requesting reclassification of the BDS.

The petition requests reclassification of the BDS and other devices in the same category from Class III status, requiring premarket approval, to Class II status permitting clearance through the less burdensome 510(k) process based on the application of general and special controls designed to assure safety and efficacy.

In addition, the submission responds to questions raised by the FDA in its December 2004 letter to the company. The company retained a leading food and drug law firm to assist with the petition. The company will continue to work with this firm as it continues through the FDA review process.