>>Policy & Regulation

US Approvals Analysis: FDA Makes Efficiency Mark For PMAs

13 Sep 2016

The US agency achieved its most efficient performance in the past 15 years for original PMA submission reviews in the most recently completed application cohort. PMA approval volumes also remain healthy. Meanwhile, 510(k) review times have leveled off and clearance volumes have dropped slightly.

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out the Approvals Tracker:https://medtech.pharmamedtechbi.com/datasets/approvals.]

The total time from submission to decision for original PMAs submitted to US FDA was the shortest it has been...