PPT-Medical Device Cybersecurity: FDA Perspective

Suzanne B Schwartz MD MBA Associate Director for Science amp Strategic Partnerships Office of the Center Director Center for devices amp Radiological Health October 19 2016 wwwfdagov Agenda. mHealth. ) . Zachary Rothstein. , Associate Vice President, Technology & Regulatory Affairs, . Advamed. Jeffrey K. Shapiro. , Director, Hyman, Phelps & McNamara, P.C. . Moderated by . Sonali Gunawardhana. June 29, 2016. DAVID KUNIN. CONSULTANT. DHKUNIN@YAHOO.COM. Why does FDA Exist?. John Updike. Prior to FDA. Prior to FDA. Prior to FDA. Dr. Wiley & FDA Poison Squad. 1906 Pure Food and Drug Act. After FDA 1970’s. Devices Applied to HIT. Bradley Merrill Thompson. Epstein Becker & . Green. June . 7, 2013 (updated June 11, 2013). 1. Roadmap. Exercise Overview . Health IT Use Case . FDA Device Regulatory Framework. A report of the typist for the Regulation Subgroup. (i.e. no one has approved this). Draft 07/11/13. Questions considered. Are . the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated. MSACL. April 4, 2019. Majda Haznadar, Kris Roth, Doug Jeffery. majda.haznadar@fda.hhs.gov. kristian.roth@fda.hhs.gov. doug.jeffery@fda.hhs.gov. www.fda.gov. www.fda.gov. DISCLAIMER. This presentation is intended for informational purposes only and does not constitute legal or regulatory advice. Please see the Federal Food, Drug, and Cosmetic Act and 21 CFR Subchapter H for a full list of requirements by FDA. A new class of non-invasive, electrical medicine begins as FDA grants a De Novo request for the first-ever body-worn stimulator to treat a movement disorder. Burlingame, CA – April 26, 2018  U.S. Food & Drug 10903 New Hampshire Avenue Doc ID# 04017.04.16 Silver Spring, MD 20993 www.fda.gov June 16, 2020 Koya, Inc. ℅ Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill USFoodDrug10903 NewHampshireAvenueDoc ID 040170420SilverSpringMD20993wwwfdagovNiCo-Lab BVNovember 20 2020 Roujuan ZhangConsultantMD Squared BVHigh Tech Campus 29Eindhoven 5858AENETHERLANDSRe K200873T CYBERSECURITY WHILE TRAVELING TIP CARD COMMON CYBERSECURITY THREATS WHILE TRAVELING Unsecured wireless networks While public wireless networks provide great convenience allowing people to connect to t New Devices. Roxana Mehran, MD, MSCAI, FACC, FAHA, FESC. Mount Sinai Professor Of Cardiovascular Clinical Research and Outcomes. Professor of Medicine (Cardiology), and Population Health Science and Policy. evaluation of evolving . computer-aided diagnosis (CAD) solutions. Kyle J. Myers, Ph.D.. Director, Division of Imaging, Diagnostics, and Software Reliability. Office. of Science and Engineering Laboratories. Epidemiological cut-off values (ECVs). Simone M. Shurland, Ph.D., . Division of Anti-Infective Products. Office of Antimicrobial Products. Office of New Drugs. Center for Drug Evaluation and Research. Get complete detail on Cybersecurity Audit exam guide to crack ISACA Certified Cybersecurity Audit. You can collect all information on Cybersecurity Audit tutorial, practice test, books, study material, exam questions, and syllabus. Firm your knowledge on ISACA Certified Cybersecurity Audit and get ready to crack Cybersecurity Audit certification. Explore all information on Cybersecurity Audit exam with number of questions, passing percentage and time duration to complete test. Get complete detail on ISACA Cybersecurity Fundamentals exam guide to crack ISACA Cybersecurity Fundamentals. You can collect all information on ISACA Cybersecurity Fundamentals tutorial, practice test, books, study material, exam questions, and syllabus. Firm your knowledge on ISACA Cybersecurity Fundamentals and get ready to crack ISACA Cybersecurity Fundamentals certification. Explore all information on ISACA Cybersecurity Fundamentals exam with number of questions, passing percentage and time duration to complete test.