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www.fdanews.com/articles/147150-fda-review-process-is-more-responsive-to-device-makers-official-says

FDA Review Process Is More Responsive to Device Makers, Official Says

June 12, 2012
Getting a medical device through the FDA’s review and on the U.S. market is a famously tough process. The science is complex. Independent reviewers have to agree that the device works and, more important, is safe for patients. Not to mention that political shakeups in Washington can quickly change the already complicated process.
The Commercial Appeal