FDA Responds to Biofield's System Reclassification Request

The FDA has conducted a review of Biofield's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct that may support other modalities such as mammography, clinical breast exam, sonography and magnetic resonance imaging used in breast cancer diagnosis.

The FDA determined that the Biofield device does not meet the criteria for Class I (General Controls) or Class II (Special Controls) classification and, therefore, falls into Class III, for which 510(k) clearance does not apply, but rather approval must be sought through a premarket approval.

"The company intends to meet shortly with the FDA to discuss regulatory pathways and data requirements," said David Long, Jr., chairman and CEO of Biofield. "The company plans to cooperate with the FDA in this process of moving forward under the format of a premarket approval."