FDA Urges Caution with Robotically Assisted Surgical Devices in Mastectomy
Sponsors must get FDA approval of investigational device exemptions for studies of robotically assisted surgical (RAS) devices intended for mastectomies to prevent or treat breast cancer, the agency said.
The FDA said it is “aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.”
In a notice aimed at healthcare providers, the FDA also cautioned that there is no confirmation of the safety and effectiveness of RAS devices for mastectomies and other breast cancer treatments.
The agency noted that it has only cleared RAS devices for certain types of cancer surgeries, such as hysterectomies, prostatectomies and colectomies, provided there is 30-day patient follow-up.