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Expert Articles

The Food and Drug Administration has made a recommendation that transvaginal mesh be reclassified as a Class III device.   Previously, transvaginal mesh had been classified as a Class II device and was required to go through the 510(k) process; however, under the new regulations, it would require premarket approval. This reclassification is the result of […]

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On July 31, 2014, the Food and Drug Administration announced to Congress that it will begin to regulate tests developed in a laboratory. These tests consist of those developed on a small scale in small laboratories. They include microscopic examinations (eg, Papanicolaou tests), examinations of sections of tissue, microbiology cultures, susceptibility tests, and erythrocyte sedimentation […]

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Knowing the regulatory environment in Europe is important given how many consumers live in the European Union. The European Union has grown over the past twenty years, and it currently has twenty-eight countries as members.  The regulatory laws of these members are governed by the European Medicines Agency (formerly known as the European Medicines Evaluation […]

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