write a paper about regulatory strategy for a product ( A ‘lab on a chip’ that allows patients to run tests on a hand held device that used to be performed in a lab. This means you can run tests that used to be sent to a lab, in your home. For example, this can be used for testing blood samples for signs of disease). This strategy must include:
• Design Input (your product description) –. You need to better define the technology by researching the product application. All of these are real technologies currently in development. Your description must included an indication for use statement, intended use description, technology description, whether single use/reusable, sold sterile/non sterile, etc. Be sure to comply with FDA’s definition of design input.
• Product Classification – provide a strong rationale of why you believe your classification is correct. Utilize FDA’s guidance for RFD submissions to the Office of Combination Products. DO NOT WRITE AN RFD. However, the guidance should guide you on how to create a persuasive argument to support your classification recommendation.
• Verification and Validation Plan – Identify the type of testing you believe FDA will require. Cite guidance documents that support your plan. It is possible that a guidance does not exist for the specific technology but there may be a guidance document for the therapeutic area and indication for use that you choose in Design Input. I am NOT looking for protocols or detailed testing objectives.
• Project Plan – List what are the major design/development phases, regulatory submissions and the Quarter/Year you expect to receive approval if you started this project today. I will not be grading to see if you get the exact length of each time period correct. I will be more focused on whether you identify all of the activities you will need to account for to get your product approved in the United States (via FDA only).
• Finally, provide a section of areas to be focused on once approval is received. Are there post approval requirements (annual reports, post marketing studies, etc.). Do you believe there will be a heavy Regulatory Maintenance cost associated with the product.
