ARTICLE SUMMARY:
Early feasibility studies are returning to the US thanks to FDA’s recent initiative. Early data indicates that the regulatory process is working smoothly, but industry and hospitals are lagging behind.
One of the chief areas of frustration for the medtech industry with the FDA in the early 2000s was the extended review times required for regulators to approve innovative devices compared with those in other countries, particularly the CE mark process in Europe. As a result, US patients were not getting access to new technologies until several years after these products were available to the rest of the world.
