Consultant Post
Dealing with FDA deficiency letters doesn’t have to be hard, read on to find out how best to address your deficiencies.
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Ever wondered how to find the best predicate for your device, read on to find out more.
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On July 10, the U.S. FDA finally released its list of medical devices that would no longer be subject to 510(k) premarket notification requirements. The list includes 1,003 Class II medical devices that have been deemed low-risk enough not to necessitate this kind of...
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Last month Commissioner Scott Gottlieb of the U.S. Food and Drug Administration made several announcements about the agency’s brand new plans to further its goal to cultivate innovation and competition in the pharmaceutical and medical device industries. The...
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By Kyla Ayers In April, President Donald Trump finally released his long-awaited tax plan. While the brief four-page document leaves many details to be desired, it introduces several groundbreaking changes for individuals, small businesses, and corporations alike....
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In a strong show of bipartisanship, Congress overwhelmingly passed the 21st Century Cures Act, which President Obama signed into law in December 2016. With promises on transforming aspects of how the FDA regulates drugs and devices, all stakeholders are closely...
