FDA seeks comments on what constitutes a ‘significant decision’
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders it strives to serve.
Disputes can occur at any stage of a particular interaction, from an initial inquiry or presubmission review to a final regulatory decision on an application or submission.