The FDA has issued a draft guidance proposing the reclassification of its regulations for full-field digital mammography (FFDM) systems and is seeking public comment and suggestions on the new proposed requirements through August 28.
The draft guidance document, published in the May 30 Federal Register, was developed as a special controls guidance to support the reclassification of the FFDM system from class III (premarket approval) to class II (special controls) when intended to produce full-field digital x-ray images of the breast. It was issued in conjunction with a Federal Register notice announcing the proposal to reclassify this device type for comment purposes only.
If a final rule to reclassify this device type is not issued, the guidance document will not be issued as a special control, according to the agency.
Following the effective date of a final rule reclassifying the device, any firm submitting a 510(k) for an FFDM system will need to address the issues covered in the control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness, the notice stated.
Any manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act, including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with FFDM Systems identified in the guidance, and (3) obtain a substantial equivalence determination from the FDA prior to marketing the device.