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The FDA Group will be hosting a free webinar on Effective Responses to FDA Warning Letters on Quality Systems.
August 13, 2014
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 […]Continue Reading
August 11, 2014
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 […]Continue Reading
August 6, 2014
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 […]Continue Reading