Challenges & opportunities associated with the regulation of robotically assisted surgery devices
Presented by Binita S Ashar at the Debate: Robotically Assisted Hernia Repair at the SAGES 2016 Annual Meeting on 3/17/2016 Keyword(s): AHSQC, cardiovascular, CDRH, Center for Devices and Radiological Health, CV, efficiency, FDA, general surgery, innovation, medical devices, mesh, orthopedic surgery, RASD, Robotically-Assisted Surgical Devices, stakeholders, technology
Testing duodenoscopes for cleaning & manual high level disinfection
Presented by Shani Haugen at the Session: OR Team – Duodenoscopes, Infections and Reprocessing. What have we learned? at the SAGES 2016 Annual Meeting on 3/19/2016 Keyword(s): disinfection, duodenoscope, EO, ethylene oxide, flex endoscope, FUJIFILM, infection, medical device, Olympus, reprocessing, Spaulding classification
Update on CRE infections- FDA perspective
Presented by Herbert Lerner at the Session: OR Team – Duodenoscopes, Infections and Reprocessing. What have we learned? at the SAGES 2016 Annual Meeting on 3/19/2016 Keyword(s): 522 studies, CMS, CRE infection, culture, device manufacturers, disinfection, duodenoscope, elevator, EO, ERCP, ethylene oxide, FDA, infection, Joint Commission, MAUDE database, MDR reporting, Olympus, recall, reprocessing, safety
Why Designing a Trial and Endpoints are Important: Markham C. Luke, M.D., Ph.D.
Device Development Luncheon: From Funding to Freedom to Operate Office of Device Eval–43 sec risk-based classification of medical devices–2:38 SE–3:26 humanitarian device exemptions–4:29 IDE–4:55 importance of clinical studies–6:58 submission types–8: Keyword(s): 510k, CDRH, clinical trials, collaboration, device development, endpoints, engineers, FDA, HDE, IDE, medical devices, Office of Device Evaluation, OUS, Pediatric Medical Device Safety & […]