The team spent 28 months and more than $45 million on the clinical trial. The PMA submission totaled over 5,000 pages and
required three detailed responses to questions from the FDA. The panel meeting was a rollercoaster, with several experts voicing
significant initial concern about the safety profile of the device. Now the official letter has arrived from the CDRH and
the team is savoring one short sentence: “You may begin commercial distribution of the device upon receipt of this letter.”
Developing an effective, strategic approach to regulation is of critical importance in the biodesign innovation process because of the time, cost, and effort associated with this work stream. Regulatory strategy is tightly ...