On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet the premarket notification requirements under section 510(k) of the Federal […]

FDA Registration, New Regulations, and GMP Standards Historically, pharmacies have been able to compound drugs for individual patients or in small batches. These compound pharmacies create and mix drugs customized to […]

This year has been somewhat up and down for medical device developers. The medical device excise tax was approved, and any devices sold starting in 2013 will be subject to […]