Weekly Vitals: Congressional Delegates Suggest Changes to FDA, TCT Turns Eyes on Industry, and More

November 11, 2011

1 Min Read
Weekly Vitals: Congressional Delegates Suggest Changes to FDA, TCT Turns Eyes on Industry, and More

Led by Minnesota senator Amy Klobuchar, 41 members of Congress signed a letter to FDA Commissioner Margaret Hamburg this week imploring the agency to expedite medical device approval times for the good of the industry, workers, and patients alike. "We share your commitment to ensuring safe and effective medical devices are available to patients. However, we are very concerned about recent declines in FDA performance. Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry," the letter states. The signees also went on to recommend several steps the agency could take to achieve a less "burdensome approach." Among their suggestions were: "recognizing and correcting the disparity between 'FDA time' versus real time when tracking device approvals; considering potential benefits of harmonization with international testing standards; addressing the unintended consequences of the conflict of interest rules for advisory panels; and creating a transparent tracking and review system for applications and clearance decisions." In other news, several interesting industry perspectives were shared at the Transcatheter Cardiovascular Therapeutics Conference (TCT), which was held in San Francisco this week. Read about these and other top stories below in this week's roundup.

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