Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

121 organizations filed 127 public comments on Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, at the Food and Drug Administration. The comment window closed 17d ago.

Abstract

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Commenters (121)

• The Christman AI Project / Luma Cognify AI. LLCunverified attribution

  5 filings · confidence 70%
• Alliance for Connected Caretrade assoc.

  2 filings · confidence 85%
• Anchor Point Health Foundationtrade assoc.

  2 filings · confidence 85%
• ACRO (Association of Clinical Research Organizations)trade assoc.

  1 filing · confidence 85%
• Administrative Tasks Inc.unverified attribution

  1 filing · confidence 70%
• AdvaMed the Medtech Associationtrade assoc.

  1 filing · confidence 85%
• Advanced Research Projects Agency for Health and the Johns Hopkins University Applied Physics Labunverified attribution

  1 filing · confidence 70%
• Advarra Incorporatedunverified attribution

  1 filing · confidence 70%
• AI Healthcare Coalitiontrade assoc.

  1 filing · confidence 85%
• Alliance for Nursing Informaticstrade assoc.

  1 filing · confidence 85%
• American Academy of Pediatrics (AAP)

  1 filing · confidence 97%
• American Association of Neurological Surgeons and Congress of Neurological Surgeonstrade assoc.

  1 filing · confidence 85%
• American Association of Nurse Anesthesiologytrade assoc.

  1 filing · confidence 85%
• American Association of Orthodontiststrade assoc.

  1 filing · confidence 85%
• American Association of Physicists in Medicinetrade assoc.

  1 filing · confidence 85%
• American Gastroenterological Associationtrade assoc.

  1 filing · confidence 85%
• American Hospital Associationtrade assoc.

  1 filing · confidence 85%
• American Medical Associationtrade assoc.

  1 filing · confidence 97%
• American Medical Informatics Associationtrade assoc.

  1 filing · confidence 85%
• American Psychiatric Associationtrade assoc.

  1 filing · confidence 85%
• American Society for Gastrointestinal Endoscopytrade assoc.

  1 filing · confidence 85%
• Arthrex Inc.unverified attribution

  1 filing · confidence 70%
• Association of periOperative Registered Nursestrade assoc.

  1 filing · confidence 85%
• Atman Health Inc.unverified attribution

  1 filing · confidence 70%
• Better Place Wellness Companyunverified attribution

  1 filing · confidence 70%
• Bettering Bearings LLCunverified attribution

  1 filing · confidence 70%
• Big Health Inc.unverified attribution

  1 filing · confidence 70%
• Bite Size Ignite Inc.unverified attribution

  1 filing · confidence 70%
• Bold Insight Inc.unverified attribution

  1 filing · confidence 70%
• Carexdata LLCunverified attribution

  1 filing · confidence 70%
• Cicero Institutetrade assoc.

  1 filing · confidence 85%
• ClaraWell Inc.unverified attribution

  1 filing · confidence 70%
• Coalition for Health AI Inc.trade assoc.

  1 filing · confidence 85%
• Coalition for State Sandboxestrade assoc.

  1 filing · confidence 85%
• Combination Products Coalitiontrade assoc.

  1 filing · confidence 85%
• Consumer Technology Associationtrade assoc.

  1 filing · confidence 97%
• Counsel Inc.unverified attribution

  1 filing · confidence 70%
• Danaher Corporationunverified attribution

  1 filing · confidence 70%
• Digital Pathology Associationtrade assoc.

  1 filing · confidence 85%
• Doctronic Inc.unverified attribution

  1 filing · confidence 70%
• Duke-Margolis Institute for Health Policytrade assoc.

  1 filing · confidence 85%
• Dun & Bradstreet Incunverified attribution

  1 filing · confidence 70%
• EG14Y Systems Incunverified attribution

  1 filing · confidence 70%
• Epic Systems Corporationunverified attribution

  1 filing · confidence 70%
• ESSKA AI & Innovation Committee (European Society of Sports Traumatologytrade assoc.

  1 filing · confidence 85%
• Ever Fortune.AI Co. Ltd.unverified attribution

  1 filing · confidence 70%
• GFLOPS Co. Ltd.unverified attribution

  1 filing · confidence 70%
• Glacis Technologiesunverified attribution

  1 filing · confidence 70%
• GNS-AI LLCunverified attribution

  1 filing · confidence 70%
• Health Innovation Alliancetrade assoc.

  1 filing · confidence 85%
• Health Trust Institutetrade assoc.

  1 filing · confidence 85%
• Hearing Industries Associationtrade assoc.

  1 filing · confidence 85%
• Hims & Hers Health Inc.unverified attribution

  1 filing · confidence 70%
• HIMSS Electronic Health Record Associationtrade assoc.

  1 filing · confidence 85%
• in2being LLCunverified attribution

  1 filing · confidence 70%
• Inc. (Ricardo Hamiltonunverified attribution

  1 filing · confidence 70%
• Infiligence Incunverified attribution

  1 filing · confidence 70%
• International Society for Pharmacoepidemiologytrade assoc.

  1 filing · confidence 85%
• iRhythm Technologiesunverified attribution

  1 filing · confidence 70%
• Japan Digital Health Alliancetrade assoc.

  1 filing · confidence 85%
• Limbic Incunverified attribution

  1 filing · confidence 70%
• LLC (dba VoxelMD)unverified attribution

  1 filing · confidence 70%
• Lune Health Inc.unverified attribution

  1 filing · confidence 70%
• Lunit Inc.unverified attribution

  1 filing · confidence 70%
• Main Street Foundation Center for Regulatory Analysis and Engagementtrade assoc.

  1 filing · confidence 85%
• March Global Inc DBA Basionunverified attribution

  1 filing · confidence 70%
• Meadows Mental Health Policy Institutetrade assoc.

  1 filing · confidence 85%
• Medical Device Manufacturers Associationtrade assoc.

  1 filing · confidence 85%
• Medical technology companyunverified attribution

  1 filing · confidence 70%
• Medicept Inc.unverified attribution

  1 filing · confidence 70%
• MetaBrain Labs Inc.unverified attribution

  1 filing · confidence 70%
• Microsoft Inc.unverified attribution

  1 filing · confidence 70%
• Middle Wave LLC / Teach & Serveunverified attribution

  1 filing · confidence 70%
• Mosaic Clinical Technologiesunverified attribution

  1 filing · confidence 70%
• National Health Counciltrade assoc.

  1 filing · confidence 85%
• Newton's Tree Incunverified attribution

  1 filing · confidence 70%
• North American Spine Societytrade assoc.

  1 filing · confidence 85%
• Oncology Nursing Societytrade assoc.

  1 filing · confidence 85%
• Palantir Technologiesunverified attribution

  1 filing · confidence 70%
• People’s Evidence Lab Inc.unverified attribution

  1 filing · confidence 70%
• Persistence Analytics Group LLCunverified attribution

  1 filing · confidence 70%
• Personalized Medicine Coalitiontrade assoc.

  1 filing · confidence 85%
• Premier Inc.unverified attribution

  1 filing · confidence 70%
• Princeton Medical Systemsunverified attribution

  1 filing · confidence 70%
• PulseMed LLCunverified attribution

  1 filing · confidence 70%
• Quality & Regulatory Expert Partners LLC (dba QRx Partners)unverified attribution

  1 filing · confidence 70%
• Radiological Society of North Americatrade assoc.

  1 filing · confidence 85%
• Ramsee 1 LLCunverified attribution

  1 filing · confidence 70%
• RecovryAI Inc.unverified attribution

  1 filing · confidence 70%
• SANCIAN LLCunverified attribution

  1 filing · confidence 70%
• SARA Society for AI in Regulatory Affairstrade assoc.

  1 filing · confidence 85%
• SAS Institute Inc.trade assoc.

  1 filing · confidence 85%
• Scarlet US Inc.unverified attribution

  1 filing · confidence 70%
• SichGate Inc.unverified attribution

  1 filing · confidence 70%
• Slingshot AI Inc.unverified attribution

  1 filing · confidence 70%
• Society for Digital Mental Healthtrade assoc.

  1 filing · confidence 85%
• Society of American Gastrointestinal and Endoscopic Surgeonstrade assoc.

  1 filing · confidence 85%
• Society of Diagnostic Medical Sonographytrade assoc.

  1 filing · confidence 85%
• Society of Quality Assurancetrade assoc.

  1 filing · confidence 85%
• SolarisRTC LLCunverified attribution

  1 filing · confidence 70%
• Stanford Institute for Human-Centered Artificial Intelligencetrade assoc.

  1 filing · confidence 85%
• Stanford University School of Medicineunverified attribution

  1 filing · confidence 70%
• Supernova Technologiesunverified attribution

  1 filing · confidence 70%
• Sustwinability LLCunverified attribution

  1 filing · confidence 70%
• Synapstak Ltdunverified attribution

  1 filing · confidence 70%
• Texas app consulting services LLCunverified attribution

  1 filing · confidence 70%
• The ALS Associationtrade assoc.

  1 filing · confidence 85%
• The Christman AI Project LLCunverified attribution

  1 filing · confidence 70%
• The Digital Medicine Societytrade assoc.

  1 filing · confidence 85%
• The Greater New York Hospital Associationtrade assoc.

  1 filing · confidence 85%
• The International Society for Pharmaceutical Engineeringtrade assoc.

  1 filing · confidence 85%
• The NSF AI Research Institute on Interaction for AI Assistantstrade assoc.

  1 filing · confidence 85%
• Tom Health LLCunverified attribution

  1 filing · confidence 70%
• U.S. Chamber of Commerce

  1 filing · confidence 97%
• University of Californiaunverified attribution

  1 filing · confidence 70%
• Vent Creativity Corporationunverified attribution

  1 filing · confidence 70%
• VitaSignal LLCunverified attribution

  1 filing · confidence 70%
• Vynix LLCunverified attribution

  1 filing · confidence 70%
• Wearlinq Inc.unverified attribution

  1 filing · confidence 70%
• Xillium LLCunverified attribution

  1 filing · confidence 70%
• ZOHRx LLCunverified attribution

  1 filing · confidence 70%