RAC Devices Practice Exam with Complete Solutions

RAC Devices Practice Exam with Complete Solutions Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANSC A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. De novo 510(k) - ANSA Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be: A. Adulteration. B. Improper use C. Misbranded D. Fraudulent - ANSC A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed? A. This requires a new 510(k) since significant change in product instructions might affect efficacy. B. After submission in a periodic report C. After reporting clinical studies in an annual report D. After submission of labeling change - ANSA Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers - ANSD A physician reports to a manufac