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Compliance In Focus
Posted by John Lehmann on Mon, Mar 5, 2012

FDA Approving Devices on Both Safety and Effectiveness

This article in Healing Innovation caught our eyes.   According to the article, unlike most of the world whose regulatory bodies approve medical devices based on safety, the FDA approves medical devices based on both safety and effectiveness.  Evaluating the effectiveness of an investigational product is what is largely responsible for the length of clinical trials that delay approval of novel medical devices.

There are some who are pushing for a new solution that would have a positive impact on the economics and provide faster access for patients of innovative therapies.  A key advocate is Dr. Andrew von Eschenback, a former FDA commissioner, who is pushing a solution that after proof of concept and safety testing, the product could be approved for marketing.

This would allow the medical device company to promote the device to every eligible patient entered in the registry so the company and FDA can establish efficacy through the post-market studies.  The main benefit would be that innovative therapies could be brought to the market faster.  Many consumer protection groups counter that the American public must be protected from unproven medical therapies.

Should the FDA consider this post-market approach?  Do the benefits of getting innovative devices to the market faster outweigh the risk of the FDA’s currently conservative approval process?  Share your thoughts.

Topics: Safety and Effectiveness, Dr. Andrew von Eschenback, FDA

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