Earlier this year, FDA published a report announcing that the Agency’s device program has shown “a pattern of markedly improved performance.” Over the past five years, FDA has been working to improve approval times for medical device submissions using the Medical Device User Fee act. The report goes on to say that all three areas have seen a reduction in review times, however IDE review times have been reduced by more than a full year, allowing medical devices to reach the market much sooner than they would have just a few years ago.
With approval times getting increasingly longer, many companies were beginning to relocate overseas or market their devices abroad before introducing them in the US. The reason for this? The FDA did not have the necessary resources and funds to get through all of the applications at a faster pace. The solution? FDA’s Medical Device User Fee program.
FDA states that approval times have been reduced for the following device submissions:
As the numbers show, the Medical Device User Fee program is clearly doing what it was intended to do, reducing the approval times for medical devices. Because of this program, FDA has the resources needed to come to decisions in a more timely manner, getting devices to the public faster.
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