FDA Oversteps on Robot Surgery Devices: Attorneys
FDA has decided to regulate novel robot assisted surgery (RAS) devices for specific indications rather than the previous tool-type indication they were cleared under in the past. Writing in a new FDALawBlog post, Hyman, Phelps & McNamara attorneys Jeffrey K. Shapiro and Allyson B. Mullen take FDA to task — calling the agency’s regulatory approach “strange” in treating RAS devices “almost as if they were therapeutics responsible for long term clinical outcomes.”
The attorneys point to an August-issued FDA surgical robot warning (see earlier story) that stated the safety and effectiveness of RAS devices for use in mastectomy procedures or in the prevention or treatment of breast cancer has not been established. “RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy,” FDA’s alert says. “These clearances are based on short-term (30 day) patient follow up. The FDA has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”
Because RAS devices aid surgeons in conducting surgery, it would be more practical if “FDA would review data on intraoperative performance and perhaps acute outcomes,” the post contends. “But these devices are not independent cancer therapeutics. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes... Although RAS devices do introduce some novelty in how the surgery is performed, they should not be treated as if they were intended to confer a specific therapeutic benefit any more than manual surgical tools would be.”
The first RAS devices were made by Intuitive Surgical and cleared as tool-type devices, claim Shapiro and Mullen, adding: “FDA has taken a hard line that each new surgical robot, as compared to Intuitive’s original robot, are not tools and each one presents new issues of safety and effectiveness due to their complex design and construction and specific indications. This approach has the perverse effect of slowing innovation in RAS devices, helping to further entrench Intuitive’s 20 year old technology.”
FDA’s new stance on RAS devices shows the agency going too far to “police the practice of medicine and surgeons’ ability to choose which tool is right for a patient’s procedure,” the attorneys contend. “To further innovation, FDA should limit itself to a review of whether a novel surgical platform is safe and effective for use in performing surgery and perhaps out to 30 days’ follow up. Anything more is unwarranted mission creep. FDA’s focus on long term clinical outcomes in surgical procedures performed with RAS devices invades a space that should be left to the practice of medicine.”