Sponsors conducting clinical trials of devices intended to treat benign prostatic hyperplasia (BPH) should conduct biocompatibility testing on the final, sterilized form of components that come in contact with patients. Such testing is necessary to demonstrate the material safety of the Class II and III devices, the FDA says in a recently released final guidance. BPH occurs when a prostate enlarges over time, obstructing the prostatic urethra and interfering with sphincter function.
Clinical Trials Advisor