1. The rise of rules: Will the new EU regulation of medical devices make us safer?
2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.
3. Shuren J. Continuing America’s leadership: the future of medical innovation for patients. Statement of Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, Food and Drug Administration Department of Health and Human Services, before the Committee on Health, Education, Labor and Pensions, United States Senate. 2015 Apr 28. Available from: http://www.help.senate.gov/imo/media/doc/Shuren3.pdf.
4. Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States
5. The US Food and Drug Administration’s New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States