FDA has used panel meetings to help it evaluate the high-risk, Class III devices that follow the PMA pathway since the 1970s but the process has changed over that time (View Highlight)
“In essence, PMAs that have gone to panel under the new system have been very likely to be approved. This suggests that FDA is generally not sending PMAs to an advisory panel unless they meet a fairly robust threshold,” they wrote. (View Highlight)
The data suggest the effectiveness vote is less influential. The study found no significant correlation between effectiveness and chances of approval, likely because three of the four PMAs rejected by FDA had positive votes on effectiveness. Most of the rejected PMAs suffered negative benefit-to-risk ratio votes. (View Highlight)
A deeper dive into the link between negative votes and approval decisions revealed that the safety and benefit-to-risk ratio rulings appear to have the most influence on FDA. Positive votes on these topics are significantly associated with the likelihood of approval. (View Highlight)