FDA Leads Revival of US Early Feasibility Studies; Can Industry Keep Up?

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The initial findings from an MDIC working group indicate that FDA’s efforts to promote early feasibility studies appear to be working to increase both the number and efficiency of these trials in the US, demonstrating that, at least on occasion, regulators can be ahead of industry. Now the burden is on device companies to follow suit.

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.

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