• Skip to main content
  • Skip to header right navigation
  • Skip to site footer

Log in
www.sages.org

SAGES

Reimagining surgical care for a healthier world

  • Home
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Awards
    • Who Is SAGES?
    • Leadership
    • Our Mission
    • Advocacy
    • Committees
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Committee Rosters
      • SAGES Past Presidents
    • Why Should You Support SAGES?
    • SAGES Swag
  • Meetings
    • SAGES NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2026 Annual Meeting
      • 2027 Scientific Session Call for Abstracts
      • 2027 Emerging Technology Call for Abstracts
    • CME Claim Form
    • SAGES Past, Present, Future, and Related Meeting Information
    • SAGES Related Meetings & Events Calendar
  • Join SAGES!
    • Membership Application
    • Membership Benefits
    • Membership Types
      • Requirements and Applications for Active Membership in SAGES
      • Requirements and Applications for Affiliate Membership in SAGES
      • Requirements and Applications for Associate Active Membership in SAGES
      • Requirements and Applications for Candidate Membership in SAGES
      • Requirements and Applications for International Membership in SAGES
      • Requirements for Medical Student Membership
    • Member Spotlight
    • Give the Gift of SAGES Membership
  • Patients
    • Join the SAGES Patient Partner Network (PPN)
    • Patient Information Brochures
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find A SAGES Surgeon
  • Publications
    • Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Sustainability in Surgical Practice
    • SAGES Stories Podcast
    • SAGES Lead Up Podcast
    • Patient Information Brochures
    • Patient Information From SAGES
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • Innovative Surgical Trends
    • SAGES Manuals
    • MesSAGES – The SAGES Newsletter
    • COVID-19 Archive
    • Troubleshooting Guides
  • Education
    • Wellness Resources – You Are Not Alone
    • Avoid Opiates After Surgery
    • SAGES Subscription Catalog
    • SAGES TV: Home of SAGES Surgical Videos
    • The SAGES Safe Cholecystectomy Program
    • Masters Program
    • Resident and Fellow Opportunities
      • MIS Fellows Course
      • SAGES Robotics Residents and Fellows Courses
      • SAGES Free Resident Webinar Series
      • Advanced Laparoscopy and Fluorescence-Guided Surgery Course for Fellows
      • Fellows’ Career Development Course
    • SAGES S.M.A.R.T. Enhanced Recovery Program
    • SAGES @ Cine-Med Products
      • SAGES Top 21 Minimally Invasive Procedures Every Practicing Surgeon Should Know
      • SAGES Pearls Step-by-Step
      • SAGES Flexible Endoscopy 101
    • SAGES OR SAFETY Video Activity
    • Foregut Video Atlas
  • Opportunities
    • Join the SAGES Patient Partner Network (PPN)
    • Fellowship Recognition Opportunities
    • SAGES Advanced Flexible Endoscopy Area of Concentrated Training (ACT) SEAL
    • Multi-Society Foregut Fellowship Certification
    • Research Opportunities
    • FLS
    • FES
    • FUSE
    • Jobs Board
    • SAGES Go Global: Global Affairs
  • Learning Hub
You are here: Home / Videos / The US FDA and Surgical innovation – Tradeoffs & Change

The US FDA and Surgical innovation – Tradeoffs & Change

 

Presented by Steven Strasberg, MD at the SAGES 2014 Meeting; Symposium: Ethics of Innovation


innovative operations vs devices–12 sec https://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
are innovative therapies research?–2:12
how do innovative operations & devices differ?–4:23


Keyword(s): 510K, AdvaMed, approval process, Belmont Report, biological effectiveness, change, chemical action, classification, cleared for sale, convenience, device related marketing, devices, ENT surgeon, ethics, fast tracking, FDA, federal government, federal regulation, formal evaluation process, fulgarization, general use, generalizable knowledge, GRADE evidence, Greenfield filter, guideline committees, Harmonic Scalpel, hiearchy of technology assessment, IHPBA, implant, in vitro reagant, industry leaders, innovative therapy, institutional regulations, invasive, IOM, IVC, LC, live donor liver resection, lobbyist, medical devices, medical products, Menaflex, National Commission for the Protection of Human Subjects of Medical & Behavioral Research, New York Times, non-validated practices, novel, OC, off label use, PE, pharmaceutical companies, PICO format, political, procedures, profit, public health, radiofrequency energy, RCT, recommendations, regulatory authorities, regulatory control, research project, RFA, safety & efficacy, scientific grounds, scientific reviewers, societal strategies, sound science, surgical innovation, sustainability, techniques, therapeutic objectives, tissue, transparency, U.S., unresectable liver tumors

Share this:

  • Share on X (Opens in new window) X
  • Share on Facebook (Opens in new window) Facebook
  • Share on LinkedIn (Opens in new window) LinkedIn
  • Share on Pinterest (Opens in new window) Pinterest
  • Share on WhatsApp (Opens in new window) WhatsApp
  • Share on Reddit (Opens in new window) Reddit
  • Share on Mastodon (Opens in new window) Mastodon
  • Share on Threads (Opens in new window) Threads
  • Share on Bluesky (Opens in new window) Bluesky
  • Print (Opens in new window) Print

Related

Video Uploaded By:
SAGES Webmaster
Uploaded on
07/11/2014
Video Categories
SAGES 2014 Meeting, Solid Organ
Learning Themes
Liver, New Technologies / Skills Acquisitions, Professional / Economic, Solid Organ
Sources
2014 Annual Meeting
Video Authors
Greenfield L, Strasberg S
Video Institutions
University of Michigan Health System--Ann Arbor MI, Washington University--St Louis MO


Hours & Info

15821 Ventura Blvd Ste 400
Encino, CA 91436

1-310-437-0544

[email protected]

Monday – Friday
8am to 5pm Pacific Time

Find Us Around the Web!

  • Bluesky
  • X
  • Instagram
  • Facebook
  • YouTube

Copyright © 2026 · SAGES · All Rights Reserved

Important Links

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

Refine Search