Request that The Commissioner of Food and Drugs Evaluate New Studies and Publish Guidance or Public Information on Robotic Mastectomy for Treatment of Breast Cancer and Update and Make Publicly Available Previous Safety Communications
Request that The Commissioner of Food and Drugs Recall all Symvess Products, Suspend Humacyte’s Biologic License, Revoke the Food & Drug Administration’s Approval of the Symvess Biologic License Application, Hold a Public Hearing on Symvess, and Disclose Humacyte/Symvess Data to the Department of Defense
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Request that the Commissioner of Food and Drugs Issue A Letter to the Centers for Medicare and Medicaid Services, A Letter to Healthcare Providers, and a Communication Letter Confirming that the Off-Label Use of the Da Vinci Robotic System and Video-Assisted Thoracoscopy (VATS) Devices to Perform the “Hybrid Convergent Cardiac Ablation” Protocolin Patients with Isolated Atrial Fibrillation Requires an Food-and-Drug-Administration Approved Investigational Device Exemption for Clinical Investigational Use, and an It Has Come To Our Attention Letter Requesting Additional Information from Intuitive Surgical and VATS Device Manufacturers, including Olympus, About Any Promotion of their Medical Devices for the “Hybrid Convergent Cardiac Ablation” Protocol
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Request that The Commissioner of Food and Drugs Reclassify the VariTrax Sternal CircumFixation System (K232986) from Class II to Class III, Require the Manufacturer to Apply for an Investigational Device Exemption (IDE) and Pre- Market Approval (PMA) Prior to Continued Clinical Use, and/or Require Postmarket Surveillance of Implanted Patients
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Request that the FDA Revise Labeling, Issue a Public Communication to Employers and Law Enforcement, and Provide Transparency Regarding 510(k) Clearance of Psychemedics Corporation’s Cannabinoid Hair Testing Device (K111929).
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Request that the Commissioner of Food and Drugs Immediately Request Intuitive Issue a Class I Recall of All Model 5 da Vinci Surgical Systems Due to a Serious Intraoperative Power Failure Defect Causing Prolonged Reboot Delay, Loss of Visualization and Control, and Potential Insufflation Loss in da Vinci 5 Models, Publish an Urgent Medical Device Safety Communication, and send a Warning Letter to Intuitive.
Request that the Commissioner of Food and Drugs Require Postmarket Surveillance, Mandate IDE and PMA Applications, Investigate Potential Misbranding, and Order a Labeling Change to Restrict enVast (K253407) to Guideline-Directed Selective/Bailout Use Only in STEMI with Persistent Large Thrombus Burden (Mar. 24, 2026)
Request that the Commissioner of Food and Drugs Investigate Mayo Clinic Promotion and Use of Robotic Nipple-Sparing Mastectomy Using the da Vinci SP Surgical System Outside the Ongoing Investigational Device Exemption; Investigate Intuitive Surgical’s Role in this Promotion; Reevaluate Clearance of da Vinci SP Surgical System for Robotic Nipple-Sparing Mastectomy (K252675); Require Post-Market Surveillance/Labeling Changes; and Communicate with CMS to Clarify IDE Status of Robotic Mastectomy and Reimbursement Implications (Mar. 2, 2026)
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