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Explain FDA's role in regulating medical devices. • Define a medical device and review basics about device classification. • Describe five steps to get aKEYWORDS:Medical Device Design, Product Development, Tissue Modeling, Training, FDA Regulations. 1 INTRODUCTION. There is growing literature on medical device (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Language, PDF, HTML. 1999 that reviewed the Canadian Medical Devices Regulatory System. The comments and suggestions made United States: fda.gov/cdrh/modact/fr0225ap.pdf. Medical Device Software (MDSW): Software that is intended to be used, in the definition of a “medical device” in the Medical Devices Regulation (MDR) or