UPDATE: Caution When Using Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA 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. The FDA continues to expect study sponsors to obtain FDA approval of investigational device exemptions (IDE) for studies of RAS devices intended for use in mastectomy procedures for the prevention or treatment of breast cancer. Studies with a potential for significant risk to study subjects, such as the use of RAS devices for mastectomy procedures or in the prevention or treatment of breast cancer, may only be conducted under an approved IDE. This helps assure adequate protections of the health, safety, and welfare of study subjects. The FDA 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. This safety communication provides: - Recommendations for patients and caregivers.
- Recommendations for health care providers.
- Recommendations for institutional review boards, clinical investigators, and study sponsors.
- Background on the issue and the FDA's actions to address the issue.
- Instructions for reporting problems with RAS devices to the FDA.
Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE). | 
No comments:
Post a Comment