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Robotic surgery for mastectomy and cancer: what the FDA has said

Patients and clinicians often ask whether a surgical robot can be used to remove a breast or treat cancer. The FDA addressed this in a safety communication first issued in 2019 and updated in August 2021.

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Documents: 15
Passages indexés: 1 610
Questions répondues: 0
Mise à jour: 8 octobre 2026

🌐 Langue des documents : Anglais

✓ Vérifiée le 7 octobre 2026

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Contenu de la base

Seuls les noms des documents sont publics. Leur contenu ne sert qu'à répondre aux questions posées à cette base, et seuls les passages cités dans une réponse sont affichés.

Caution When Using Robotically-Assisted Surgical Devices in Women's Health incl. Mastectomy — FDA Safety Communication (2021 update)
Computer-Assisted Surgical Systems — Overview, Safety Communications and Clearances (FDA)
Medical Device Reporting for Manufacturers — Final Guidance (FDA)
21 CFR Part 803 — Medical Device Reporting (eCFR)
21 CFR Part 820 — Quality Management System Regulation (QMSR), aligned with ISO 13485 (eCFR)
21 CFR 876.1500 — Endoscope and accessories (eCFR)
Software as a Medical Device (SaMD) — Clinical Evaluation, IMDRF Guidance Adopted by FDA
Robotically-Assisted Surgical Devices — Premarket Submissions, DRAFT Guidance (FDA)
De Novo Classification Process — Evaluation of Automatic Class III Designation (FDA)
The 510(k) Program — Evaluating Substantial Equivalence in Premarket Notifications (FDA)
Artificial Intelligence-Enabled Device Software Functions — Lifecycle Management and Marketing Submission Recommendations, DRAFT Guidance (FDA)
Marketing Submission Recommendations for a PCCP for AI-Enabled Device Software Functions — Final Guidance (FDA)
Applying Human Factors and Usability Engineering to Medical Devices — Final Guidance (FDA)
Cybersecurity in Medical Devices — Quality Management System Considerations and Content of Premarket Submissions (FDA)
Content of Premarket Submissions for Device Software Functions — Final Guidance (FDA)

Authorization status for cancer uses

The FDA states that it has not granted marketing authorization for any robotically-assisted surgical device for the prevention or treatment of cancer, including breast cancer. The labeling of legally marketed devices says that cancer treatment outcomes with the device have not been evaluated by the FDA.

The FDA has cleared these devices for laparoscopic procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgery, but not for mastectomy.

Why the evidence falls short

FDA reviews have generally focused on whether the complication rate at 30 days is comparable to other techniques. For cancer uses, the FDA expects outcomes such as local recurrence, disease-free survival or overall survival over periods much longer than 30 days.

The communication mentions limited, preliminary evidence that robotic surgery for cancers that mainly or only affect women may be associated with lower long-term survival (other researchers found no statistically significant difference).

Questions fréquentes

What should patients ask their surgeon?

The FDA suggests asking about the surgeon's training, experience and patient outcomes with robotic procedures, how many similar procedures they have performed, and which complications can occur and how often.

How can a complication be reported?

The FDA encourages patients and providers to file a report through MedWatch, its safety information and adverse event reporting program. Staff of facilities subject to user facility reporting should follow their facility's procedures.

Can a clinical study test a new cancer use of a marketed robot?

Yes, but clinical studies in the United States that investigate a new intended use of a legally marketed device are subject to FDA oversight under the Investigational Device Exemption framework.

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{
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