RAS devices utilize software technology to enable a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions for instrument access while viewing the surgical site on a screen in high definition imaging.
In its latest safety communication, FDA acknowledged 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. FDA notes that while RAS “is an important treatment option that is safe and effective when used appropriately and with proper training, the FDA has not granted marketing authorization for any RAS device system for use in the United States specifically for the prevention or treatment of cancer.” FDA’s clearances for such devices have been for limited indications and FDA has not evaluated outcomes such as overall survival, recurrence, and disease-free survival needed for establishing the safety or effectiveness of RAS devices for use in the prevention or treatment of cancer.
This safety communication provides recommendations for patients, caregivers, health care providers, institutional review boards (IRBs), clinical investigators, and study sponsors. FDA recommends that health care providers:
- Obtain appropriate credentialing and training for the specific RAS device procedures intended to be performed
- Discuss with patients their experience and training, as well as clinical outcomes expected with the use of RAS devices
- Discuss with patients the benefits, risks, and alternatives of all available treatment options
- File a report through MedWatch (the FDA Safety Information and Adverse Event Reporting program) if patients experience adverse effects or complications with a RAS device
Advising IRBs, clinical investigators, and study sponsors, FDA warned that:
- Clinical studies for mastectomy and for the prevention or treatment of breast cancer using RAS devices must include monitoring of long-term clinical outcomes, such as cancer recurrence, disease-free survival, and overall survival
- Clinical studies for mastectomy and the prevention and treatment of breast cancer should include safeguards such as study stopping rules and periodic reporting to FDA
- RAS devices intended for the prevention and treatment of other cancers being studied clinically require an IDE
The agency also urged academic and research institutions, professional societies, RAS device experts, and manufacturers to establish patient registries to gather real-world evidence on the use of RAS devices for all uses, including the prevention and treatment of cancer. FDA said it continues to monitor adverse events reported to the FDA to inform its understanding of the benefits and risks of RAS devices when used for specific indications.
If you have any questions on the use of robotically-assisted surgical devices, or on adverse event reporting or investigational device exemptions more generally, you may contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.
Authored by Randy Prebula, Lina Kontos, Kristin Zielinksi Duggan, Kelliann Payne, and Janice Hogan
