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 (NYSE:JNJ) 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 warning Depuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.
“Custom medical devices, which are provided at a physician’s request to meet a specific patient need, have been an allowed exemption to FDA premarket review under the Food, Drug, and Cosmetic Act since 1976,” the company wrote in a statement. “While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices.”
That includes all custom devices, not just the dozen or so listed in the warning letter, and the hold is permanent, Depuy spokeswoman Jessica Masuga confirmed with MassDevice.
The company also plans to address quality issues cited in the FDA letter, according to the statement.