The agency has really pushed the envelope regarding abbreviated device applications. We're allowing many products that previously would have required a comprehensive application to now be reviewed under an abbreviated application, which is usually processed in only 90 days. We may be able to reduce review times by allowing carefully selected outside groups to perform the first stage of review of devices that don't present a substantial risk to the American public. A. Today, medical device manufacturers may have to develop different sets of data for each country in which they seek approval. We are working toward harmonizing standards among countries where we can.
People are much the same around the world, and many of their diseases and injuries are the same.
We ought to be able to reach agreement worldwide on what constitutes a safe, well-manufactured product. But the issue of whether a product delivers a sufficient benefit is harder because there are different expectations of the regulatory systems in the United States and, for example, Europe. The United States has the gold standard for what is expected from companies when they want to bring a product to market, a gold standard not just in terms of knowing how a product is made but also of knowing how it works and under what circumstances it works. We're not prepared to take a step down to a lower standard, and other countries with different expectations of government aren't ready to line up with the American system. So we don't expect to see total harmonization soon, with one reviewing body getting the product to the world market.