RAC Practice Exam Latest Updated 2024 With Complete SolutionsYou have modified your 510(k)-cleared device with a Special 510(k). In which casewould a Special 510(k) not be appropriate for the device? - You have changed theprimary mechanism of action.Which Premarket Approval Application (PMA) supplements are NOT subject to userfee exemption? - Real Time SupplementA medical device company allows its sales force to maintain a product inventory inthe field. The device has an expiration date indicated on its labeling. A sales personnotes that one of his products has expired and contacts the headquarters officefor direction. He is told to return the product to the headquarter office forreplacement. The return of this product is considered as what type of recall? -Not a recall—it is considered normal stock rotationA company is developing an (unapproved) drug-device combination product but isnot sure to which center it should submit its marketing application. The companyshould first submit - A Request for Designation to the Office of CombinationProductsA medical device company is developing a product with drug, biologic and devicecomponents. The product and indication have not been previously classified byFDA. What is the most appropriate regulatory pathway? - A Request forDesignation (RFD) should be sent to the Office of Combination Products (OCP) atFDA to determine the primary mode of action (PMOA) and assign the agency withprimary jurisdiction.Preview Mode
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