The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance Tuesday to support clinical testing of high-intensity ultrasound systems for prostate tissue ablation devices.
The 10-page draft guidance outlines clinical investigation recommendations for the devices and includes benefit-risk determinations in premarket regulatory decisions that are “flexible in some cases” and “tailored to the type and intended use of the device.” The release of the guidance comes as CDRH previously granted SonaCare Medical’s de novo classification request in 2015 for its high intensity ultrasound system for prostate tissue ablation.
The guidance’s scope is limited to clinical investigations to support the marketing authorization for general indications for prosthetic tissue ablation systems and does not address the clinical investigations for specific disease treatments.
Data “should collectively provide evidence of the extent to which the intended region of tissue is ablated to support marketing authorization,” CDRH says. Device safety “should be assessed in a separate cohort of patients who are similarly treated with the ablation device and prospectively followed for one year post-ablation” if a “treat and resect” study is used to assess effectiveness…