A Medical Device Daily

As it earlier promised, Biofield (Atlanta), developer of the Biofield Breast Proliferation Rate Detection System (BDS), a non-invasive, radiation-free adjunctive test system that the company says “may be of assistance in the evaluation of suspicious breast lesions,“ reported submitting a petition to the FDA requesting reclassification of the system.

The petition requests reclassification of the BDS and other devices in the same category from Class III status, requiring premarket approval (PMA), to Class II status permitting clearance through the 510(k) process. In addition, the submission responds to questions raised by the FDA in its December letter to the company.

In that letter, the FDA said that the device was not equivalent to devices already on the market and therefore not eligible for 510(k) clearance. The agency classified the BDS as a Class III device, requiring a PMA and likely to take up to a year or more to complete.

David Long Jr., MD, PhD, chairman and CEO of Biofield, said, “The petition for reclassification is the next step in the process of pursuing clearance for our product. In filing the petition we also responded to the questions that the FDA raised in its initial review and will continue to work closely with the agency regarding any other questions that they may have.“

Biofield has developed a non-invasive system to be used adjunctively in the evaluation of suspicious breast lesions. “The BDS may reduce diagnostic uncertainty as well as decrease the incidence of missed cancers,“ according to the company.

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