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 http://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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