DEVICE RAC EXAM Questions and Answers Graded A+ 2023 update

DEVICE RAC EXAM Questions and Answers Graded A+ 2023 update 1. 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: answer- C 2. A company wants to modify its legally marketed device such that the mod- ification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet 2 / 14 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): answer- A 3. 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: answer- C 4. A company's competitor is marketing a Class II suture which dissolves dur- ing 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 3 / 14 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: answer- A 5. Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers