Amy J. Reed Collaborative/HARMS Petitions FDA to Rescind Robotic Mastectomy Clearance

02.19.26 — Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC) and Harmed Americans for Reform in Medical-Device Safety (HARMS), have filed a petition with the U.S. Food and Drug Administration (FDA) requesting that the Commissioner of Food and Drugs immediately rescind or amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by removing “Nipple Sparing Mastectomy (NSM) Procedures” from indications for use until long-term oncologic safety and non-inferiority data are established.

“The United States Food and Drug Administration has acted in an arbitrary and capricious way by clearing robotic mastectomy as a treatment for breast cancer using the 510(k) pathway because the agency knows that this device indication has been deemed to be a ‘significant risk’ treatment and is currently the subject of an IDE clinical trial,” said Noorchashm, an internationally recognized medical device safety expert. “This is either a significant regulatory error or fraud at the FDA.”

“The FDA has ignored its own warnings for this precise indication without the complete data from the FDA- and CMS-approved clinical trial. Not only does this clearance undermine public trust; it also poses a threat to patient safety and the proper functioning of clinical investigations,” said Simon, a healthcare law expert.

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability. Harmed Americans for Reform in Medical-Device Safety (HARMS) is a 501(c)(3) not-for-profit corporation. Its mission is to advance medical device safety through advocacy, outreach and organizing.

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