Device Trials Driven Overseas By Cost, Ease of Patient Recruitment

Device companies will continue to develop products abroad as long as financial and regulatory conditions overseas are more favorable than in the U.S., warned experts at the Food & Drug Law Institute annual meeting in Washington, D.C. Moving a 510(k) product to market typically took half the time in Europe that it did in the U.S. — nine months versus 18 months, said Andy Van Houten, associate general counsel at AdvaMed, citing a recent industry study. The difference is even larger for premarket approval applications, which average 54 months in the U.S., compared with just 11 months in the EU.
Clinical Trials Advisor