Giardina, Steve Ph.D.Smith, Oney Ph.D.Steele, David D.V.M.Borek, Mary Lisa2019-04-012019-04-012019-01http://hdl.handle.net/11603/13291Research to develop a 510(k) checklist/inventory of steps based on the phases of development for a Class II medical device working towards a 510(k) submission to the FDA. The 510(k) Inventory Tool was developed to be an effective tool to consistently identify important regulatory deliverables, refine regulatory direction, and ensure that technical requirements are adequately addressed during medical device development. The final 510(k) Inventory Tool is available from the author upon request.Designing and developing medical devices is a complex undertaking with significant opportunities, dependencies, and risks for the stakeholders. This capstone project explores the concept of developing a tool for the regulatory professional with a goal of improving both the quality of regulatory engagement in medical device development and product development efficiency, specifically in cases where the 510(k) FDA regulatory approval process is being used. This is accomplished by creating a checklist tool, the 510(k) Inventory Tool, utilizing published data about known 510(k) submission deficiencies and post-market device reports, then integrating these checklists into appropriate points in the medical device development process, leveraging traditional phase gate project methodologies. By exercising the 510(k) Inventory Tool within the medical device development process, the regulatory affairs professional would have a checklist tool to facilitate project team engagement, to generate stage-appropriate regulatory discussion, and to develop measured strategies for project risk mitigation during the development lifecycle.64 pagesen-USAttribution-NonCommercial-NoDerivs 3.0 United Stateshttp://creativecommons.org/licenses/by-nc-nd/3.0/us/Regulatory AffairsMedical Device Development510(k)FDAFood and Drug AdministrationText