September 1, 2014

AdvaMed Tries Public Diplomacy to Handle Swinging FDA

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

One of the most entertaining aspects of those great Rocky boxing movies is the impossible number of punches fighters land in each round. In Rocky Balboa , for example, the challenger throws more than sixty punches in the first round…that comes out to a punch about every three seconds.

As we’ve been showing in some recent blogs, it appears AdvaMed and the FDA are looking to start their own fighting franchise.

When FDA’s Jeffrey Shuren, director of the Center For Devices and Radiologic Health, recently labelled AdvaMed’s 510(k) study “highly flawed,” here he landed a pretty good hook to the jaw. But AdvaMed got up off the canvas today (Dec. 2), though it went more for a diplomatic Tai Chi approach by trying to take the FDAs energy and moving it in another, less industry-threatening direction.

“AdvaMed is pleased that Dr. Shuren’s remarks are a strong statement recognizing the need to improve CDRH’s effectiveness in supporting innovation and with his commitment to an interactive premarket review process that is predictable, consistent, transparent and timely,” commented AdvaMed President and CEO Stephen J. Ubl.

Ubl said Shuren’s comments “reflect support for common sense 510(k) reform recommendations that will address some of the most critical problems at the Center – recommendations for enhanced guidance and standard operating procedures, greater transparency and clarification of review requirements, and increased training for Center staff and industry.”

AdvaMed’s Ubl strained himself to put a good face on FDA’s tough public reaction to its Stanford Survey. “As the reform process moves forward, we look forward to continuing to work cooperatively with Dr. Shuren and his staff. There are a number of areas where broad support for needed changes exists. These points of agreement should serve as a foundation for future reform efforts. Such an approach would improve the 510(k) process and would avoid proposals that could have a negative impact on innovation and patients.” So, who would win in a computer fight? Rocky or Bruce Lee? Guess we’re going to find out.

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  1. [...] device innovation, enhancing regulatory predictability, and improving patient safety. As we’ve blogged elsewhere, AdvaMed and some others are wary that the agency will stifle medical device innovation if it acts [...]

  2. [...] most device industry groups are cautiously praising the FDA, with a few exceptions, such as AdvaMed’s Stanford University report. Privately, most device makers tell us FDA is going overboard and will stifle medical [...]

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