Industry: FDA Needs to Redraft Two Proposed CAD Guidances

Two draft guidances on computer-assisted detection (CAD) devices, one on 510(k) submissions and the other on clinical performance assessments, are so burdensome that they could kill future innovation by requiring extensive and unnecessary testing, industry representatives and experts told the Radiological Devices Panel last week during a meeting. Industry “is on the threshold of not having these products at all. If it’s not economical, development isn’t going to happen,” Morgan Nields, industry expert and CEO of Intio, an oncology visualization device company, warned.
Devices & Diagnostics Letter