The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities.”
The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS technologies. The participants of this workshop will discuss current challenges and opportunities related to RAS devices and address clinical, technical and training questions related to the safe and effective use of these devices.
- Date, Time and Location
- Federal Register Notice
- Discussion Paper
- Discussion Paper – Appendix 1
- Agenda
- Webcast
- Registration
- Contact Us
FDA Campus Information
WelcomeBinita Ashar, M.D., M.B.A.
Center for Devices and Radiological Health (CDRH), FDA8:10 AM – 8:30 AMU.S. Food and Drug Administration (FDA) VisionWilliam H. Maisel, M.D., M.P.H.
CDRH, FDA
CHALLENGES AND OPPORTUNITIES I
What are the key fundamental technological and performance characteristics for a new RASD platform? What are the key fundamental technological and performance characteristics for iterative changes to marketed RASD platforms?
CHALLENGES AND OPPORTUNITIES II
How should interoperability among RASD platforms and and other medical devices intended for use with those platforms (including those from different manufacturers) be assessed? What sort of evidence, if any, should be provided? Should interoperability be promoted?
Moderators: Binita Ashar, M.D., M.B.A. Dwight Yen, M.S.
8:30 AM – 8:45 AMRASD: An FDA PerspectiveJoshua Nipper, M.E.
CDRH, FDA8:45AM – 9:05 AMEssential Performance Characteristics of RASDRussell Taylor, Ph.D.
Johns Hopkins University9:05 AM – 9:15 AMInteroperabilityPeter Kazanzides, Ph.D.
Johns Hopkins University9:15 AM – 9:40 AMPanel Discussion:
Bench Testing
Pre-clinical TestingPeter Kazanzides, Ph.D.
Johns Hopkins University
Jacob Rosen, Ph.D.
University of California, Los Angeles
Russell Taylor, Ph.D.
Johns Hopkins University
Joshua Nipper, M.E.
CDRH, FDA
Howie Choset, Ph.D.
Carnegie Mellon University9:40 AM – 9:55 AMAudience QA9:55 AM – 10:15 AMPanel Discussion:
New Innovation Interoperability10:15 AM – 10:30 AMAudience QA10:30 AM – 10:45 AMBreakCHALLENGES AND OPPORTUNITIES III
What are the considerations when distinguishing between “general” use indications and “specific” indications for RASD?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D.10:45 AM – 11:00 AMBackground and Clinical Utility of RASD Marketed with General ClaimsLevel of Evidence Used to Justify General IndicationsDaniel Herron, M.D.
Mount Sinai Hospital11:15 AM – 12:00 PMPanel Discussion:
Define General Surgery
Types of Procedures
Scope and Limitations
Other General IndicationsGeneral SurgerySteven Schwaitzberg, M.D.
University of Buffalo School of Medicine1:15 PM – 1:30 PMUrologyVipul Patel, M.D.
Florida Hospital Global Robotics Institute1:30 PM – 1:45 PMGynecologyColorectalVincent Obias, M.D.
George Washington University2:00 PM – 3:00 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness Endpoints Arnold Advincula, M.D.
Columbia University Medical Center
Vincent Obias, M.D.
George Washington University
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Steven Schwaitzberg, M.D.
University of Buffalo School of Medicine3:00 PM – 3:15 PMAudience QA3:15 PM – 3:30 PMBreakCHALLENGES AND OPPORTUNITIES IV
Under what circumstance are additional data needed to support indications for specific surgical procedures, when a RASD is already cleared for general use?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 3:30 PM – 3:45 PMEar, Nose Throat (ENT)Gregory Weinstein, M.D.
University of Pennsylvania3:45 PM – 4:00 PMCardiothoracicRandolph Chitwood, M.D.
East Carolina University Brody School of Medicine4:00 PM – 4:15 PMNewly Enabled SurgeriesDana Portenier, M.D.
Duke Univesity Medical Center4:15 PM – 5:05 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness EndpointsRandolph Chitwood, M.D.
East Carolina University Brody School of Medicine
Myriam Curet, M.D.
Intuitive Surgical Inc.
Dana Portenier, M.D.
Duke Univesity Medical Center
Gregory Weinstein, M.D.
University of Pennsylvania5:05 PM – 5:20 PMAudience QA5:20 PM – 5:30 PMAdjournJoshua Nipper, M.E.
CDRH, FDA
July 28, 2015 – Day 2
TimeEventSpeaker/Panelist7:30 AM – 8:00 AMRegistration8:00 AM – 8:05 AMWelcome – Recap of Day 1Binita Ashar, M.D., M.B.A.
CDRH, FDACHALLENGES AND OPPORTUNITIES V
What is the role of training and simulation during premarket evaluation in ensuring device usability and mitigating risk? How should they be assessed?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 8:05 AM – 8:20 AMTraining and Credentialing in New TechnologiesImplementation of a RASD Training ProgramRichard Satava, M.D.
University of Washington Medical Center8:35 AM – 8:50 AMValidation of Surgical Simulators for RASDRoger Smith, Ph.D.
Florida Hospital Nicholson Center8:50 AM – 9:05 AMRobotic Training NetworkIsabel Green, M.D.
Johns Hopkins School of Medicine9:05 AM – 10:15 AMPanel Discussion:
Manufacturer Responsibilities
Role of Professional Societies
Credentialing
Role of SimulatorsIsabel Green, M.D.
Johns Hopkins School of Medicine
Dennis Fowler, M.D.
Titan Medical Inc.
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Adrian Park, M.D.
Anne Arundel Medical Center
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Ajit Sachdeva, M.D.
American College of Surgeons
Richard Satava, M.D.
University of Washington Medical Center
Roger Smith, Ph.D.
Florida Hospital Nicholson Center10:15 AM – 10:30AMAudience QA10:30 AM – 10:45 AMBreakCHALLENGES AND OPPORTUNITIES VI
How can collaboration among all stakeholders be promoted to improve and create data sources that can be efficiently leveraged for multiple purposes?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 10:45 AM – 11:00 AMMedical Device Epidemiology Network Initiative (MDEpiNet)Benjamin C Eloff, PhD
Senior Scientific Program Manager
Division of Epidemiology11:00 AM – 11:15 AMIdea, Development, Exploration, Assessment, Long-term follow up (IDEAL) FrameworkArt Sedrakyan, M.D.
Weill Cornell Medical College11:15 AM – 12:10 PMPanel Discussion:
Use of Published Literature and other Data SourcesMyriam Curet, M.D.
Intuitive Surgical Inc.
David Earle, M.D.
Tufts University Medical School
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Ajit Sachdeva, M.D.
American College of Surgeons
Art Sedrakyan, M.D.
Weill Cornell Medical College12:10 PM – 12:25 PMAudience QA12:25 PM – 12:45 PMPublic Comment12:45 PM – 1:00 PMClosing: Workshop SummaryBinita Ashar, M.D., M.B.A.
CDRH, FDA
Webcast
July 27
July 28
[email protected].
[email protected].
Germarie Sanchez-Pomales, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, Phone: 301-796-4573, Email: [email protected].
Center for Devices and Radiological Health (CDRH), FDA8:10 AM – 8:30 AMU.S. Food and Drug Administration (FDA) VisionWilliam H. Maisel, M.D., M.P.H.
CDRH, FDA
What are the key fundamental technological and performance characteristics for a new RASD platform? What are the key fundamental technological and performance characteristics for iterative changes to marketed RASD platforms?
How should interoperability among RASD platforms and and other medical devices intended for use with those platforms (including those from different manufacturers) be assessed? What sort of evidence, if any, should be provided? Should interoperability be promoted?
Moderators: Binita Ashar, M.D., M.B.A. Dwight Yen, M.S.
CDRH, FDA8:45AM – 9:05 AMEssential Performance Characteristics of RASDRussell Taylor, Ph.D.
Johns Hopkins University9:05 AM – 9:15 AMInteroperabilityPeter Kazanzides, Ph.D.
Johns Hopkins University9:15 AM – 9:40 AMPanel Discussion:
Bench Testing
Pre-clinical TestingPeter Kazanzides, Ph.D.
Johns Hopkins University
Jacob Rosen, Ph.D.
University of California, Los Angeles
Russell Taylor, Ph.D.
Johns Hopkins University
Joshua Nipper, M.E.
CDRH, FDA
Howie Choset, Ph.D.
Carnegie Mellon University9:40 AM – 9:55 AMAudience QA9:55 AM – 10:15 AMPanel Discussion:
New Innovation Interoperability10:15 AM – 10:30 AMAudience QA10:30 AM – 10:45 AMBreakCHALLENGES AND OPPORTUNITIES III
What are the considerations when distinguishing between “general” use indications and “specific” indications for RASD?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D.10:45 AM – 11:00 AMBackground and Clinical Utility of RASD Marketed with General ClaimsLevel of Evidence Used to Justify General IndicationsDaniel Herron, M.D.
Mount Sinai Hospital11:15 AM – 12:00 PMPanel Discussion:
Define General Surgery
Types of Procedures
Scope and Limitations
Other General IndicationsGeneral SurgerySteven Schwaitzberg, M.D.
University of Buffalo School of Medicine1:15 PM – 1:30 PMUrologyVipul Patel, M.D.
Florida Hospital Global Robotics Institute1:30 PM – 1:45 PMGynecologyColorectalVincent Obias, M.D.
George Washington University2:00 PM – 3:00 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness Endpoints Arnold Advincula, M.D.
Columbia University Medical Center
Vincent Obias, M.D.
George Washington University
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Steven Schwaitzberg, M.D.
University of Buffalo School of Medicine3:00 PM – 3:15 PMAudience QA3:15 PM – 3:30 PMBreakCHALLENGES AND OPPORTUNITIES IV
Under what circumstance are additional data needed to support indications for specific surgical procedures, when a RASD is already cleared for general use?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 3:30 PM – 3:45 PMEar, Nose Throat (ENT)Gregory Weinstein, M.D.
University of Pennsylvania3:45 PM – 4:00 PMCardiothoracicRandolph Chitwood, M.D.
East Carolina University Brody School of Medicine4:00 PM – 4:15 PMNewly Enabled SurgeriesDana Portenier, M.D.
Duke Univesity Medical Center4:15 PM – 5:05 PMPanel Discussion
Evaluation of Specific Procedures
Benefit / Risk Assessments
Safety and Effectiveness EndpointsRandolph Chitwood, M.D.
East Carolina University Brody School of Medicine
Myriam Curet, M.D.
Intuitive Surgical Inc.
Dana Portenier, M.D.
Duke Univesity Medical Center
Gregory Weinstein, M.D.
University of Pennsylvania5:05 PM – 5:20 PMAudience QA5:20 PM – 5:30 PMAdjournJoshua Nipper, M.E.
CDRH, FDA
CDRH, FDACHALLENGES AND OPPORTUNITIES V
What is the role of training and simulation during premarket evaluation in ensuring device usability and mitigating risk? How should they be assessed?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 8:05 AM – 8:20 AMTraining and Credentialing in New TechnologiesImplementation of a RASD Training ProgramRichard Satava, M.D.
University of Washington Medical Center8:35 AM – 8:50 AMValidation of Surgical Simulators for RASDRoger Smith, Ph.D.
Florida Hospital Nicholson Center8:50 AM – 9:05 AMRobotic Training NetworkIsabel Green, M.D.
Johns Hopkins School of Medicine9:05 AM – 10:15 AMPanel Discussion:
Manufacturer Responsibilities
Role of Professional Societies
Credentialing
Role of SimulatorsIsabel Green, M.D.
Johns Hopkins School of Medicine
Dennis Fowler, M.D.
Titan Medical Inc.
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Adrian Park, M.D.
Anne Arundel Medical Center
Vipul Patel, M.D.
Florida Hospital Global Robotics Institute
Ajit Sachdeva, M.D.
American College of Surgeons
Richard Satava, M.D.
University of Washington Medical Center
Roger Smith, Ph.D.
Florida Hospital Nicholson Center10:15 AM – 10:30AMAudience QA10:30 AM – 10:45 AMBreakCHALLENGES AND OPPORTUNITIES VI
How can collaboration among all stakeholders be promoted to improve and create data sources that can be efficiently leveraged for multiple purposes?
Moderators: Binita Ashar, M.D., M.B.A. Steven Nagel, M.D. 10:45 AM – 11:00 AMMedical Device Epidemiology Network Initiative (MDEpiNet)Benjamin C Eloff, PhD
Senior Scientific Program Manager
Division of Epidemiology11:00 AM – 11:15 AMIdea, Development, Exploration, Assessment, Long-term follow up (IDEAL) FrameworkArt Sedrakyan, M.D.
Weill Cornell Medical College11:15 AM – 12:10 PMPanel Discussion:
Use of Published Literature and other Data SourcesMyriam Curet, M.D.
Intuitive Surgical Inc.
David Earle, M.D.
Tufts University Medical School
Dmitry Oleynikov, M.D.
University of Nebraska Medical Center
Ajit Sachdeva, M.D.
American College of Surgeons
Art Sedrakyan, M.D.
Weill Cornell Medical College12:10 PM – 12:25 PMAudience QA12:25 PM – 12:45 PMPublic Comment12:45 PM – 1:00 PMClosing: Workshop SummaryBinita Ashar, M.D., M.B.A.
CDRH, FDA
[email protected].
