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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

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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

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