FDA’s Guidance on Prostate Tissue Ablation Devices Called ‘Too Restrictive’

The FDA’s draft guidance on clinical testing for prostate tissue ablation devices is too restrictive, industry groups said in written comments to the agency.

The draft guidance provides clinical testing recommendations for devicemakers seeking a general indication for ablation of prostate tissue, whether by high intensity ultrasound or alternative technologies. The FDA said the guidance is intended for a general indication for ablation of prostate tissue and does not address treatment for a specific disease such as prostate cancer.

AdvaMed said it generally supports the FDA’s approach in the draft, but it called for some changes to the draft guidance CDRH released in June.