The course is (Strategic Planning and Project Management for Regulatory Affairs).
The goal of the Course paper is to describe the regulatory strategy to be granted a De Novo classification request for a medical device (t:Slim X2 insulin pump) that would be determined by FDA to be Class III.
The Strategy should contain the following information:
• Device name and description
• Intended Use / Indications for Use
• Technological characteristics
De Novo classification request will utilize:
• Risk analysis to demonstrate that the medical device is Class II and not Class III due to reduced patient safety risks and associated mitigations
• Regulatory Intelligence
• On the device and its packaging, including Instructions for Use
Supporting information to ensure that the device is safe and effective, and that device is not Class III
– For information on De Novo Classification of this device (T:slim X2 Insulin Pump), see:
– For information on De Novo Classification, see:
Course paper instructions:
o The paper shall be a minimum of 15 pages, double-spaced, one-inch margins. This does not include the cover page and references/citations.
o The text shall be 12 point Times Roman font
o Each page shall be numbered
o Originality: the paper must be written in your own words. Including paragraphs from other sources (even if properly cited, e.g., with quotes) is not allowed. You are responsible for the originality of your paper. It is advised that you review the Turnitin analysis of your submitted paper.
o References shall be used to support your analysis and conclusions. When you cite sources from the Internet, do not cite only the URL where you found the source. Instead, provide the title of the source; the date that you last accessed the source and the URL.
Type of service-Academic paper writing
Type of assignment-Term Paper
Pages / words-15 / 4125
Number of sources-5
Academic level -Master’s
Language style-US English