Federal regulators have authorized the first Class III medical device specifically indicated for distal cholangiocarcinoma, a rare bile duct cancer with a reported median overall survival of about 6.7 months when it cannot be surgically removed. The OncoSil device delivers radioactive phosphorus-32 microparticles directly into the tumor.
The clearance came through the Humanitarian Device Exemption pathway, and that detail changes the meaning of the authorization. An HDE does not require the manufacturer to demonstrate reasonable assurance of effectiveness, the standard applied under premarket approval. It requires the FDA to determine that the probable benefit outweighs the risk for a condition affecting no more than 8,000 people in the United States annually.
