J&J's Depuy to stop selling all custom devices in response to FDA warning (MassDevice)
Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components.
Johnson & Johnson subsidiary DePuy Orthopaedics decided to stop selling all custom fitted devices in response to an FDA warning following an inspection of the Warsaw, Ind.-based company's facilities.
This week the FDA's Centers for Devices & Radiological Health released a letter wa...