FDA Seeks Comment on 3-D Printing of Medical Devices
The FDA published a discussion paper regarding 3-D printing medical devices at the point of care (PoC), such as hospitals and doctor’s offices, and is open for public comment until February 10. The discussion paper provides relevant background, brief overview of FDA regulation of devices and 3-D printing, and how capabilities at a 3-D printing facility factor into device safety and effectiveness. The comment period allows for a potential approach for regulatory oversight under various scenarios to inform future policy development.
Read more about the discussion paper.
FDA issues de novo clearance for SonoMotion’s Stone Clear device, for kidney stone treatment
Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.
