FDA’s proposed program accelerates marketing approval for high-risk medical devices

April 29, 2014 | Reply More

The U.S. Food and Drug Administration recently proposed a program that aims to accelerate marketing approval for high-risk medical devices. The FDA’s proposed Expedited Access Premarket Approval Application program was offered in response to criticisms that the FDA’s process for approving medical devices is both lengthy and inefficient, and denies patients access to new, innovative products. To be eligible for the FDA’s new program, devices must feature breakthrough technology and have significant benefits over existing products. The program isn’t a new pathway to market, says the FDA, but rather a change in approach that is intended to reduce the time it takes to develop a product and get it to market.

At this year’s Convergence Summit, Brad Thompson, Attorney at Epstein Becker Green PC and Stephanie Zaremba, Senior Manager of Government and Regulatory Affairs at Athenahealth, will engage in a friendly debate concerning the need for legislation to achieve the FDA’s stated goals of protecting patient safety and promoting innovation to improve public health. See the full Convergence Summit agenda here: http://bit.ly/1mQ0NAr

Read the full article here: http://in.reuters.com/article/2014/04/22/fda-medicaldevice-idINL3N0NE3OT20140422

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