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, […]