Device RAC Exam Questions and Answers

Which division has 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. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. 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) - ANSWER-A. Special 510(k) A Special 510(k) is allowed if a modification to the legally marketed device is being made that relies on compliance with design controls, including design validation. The incentive provided for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30 days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. 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. Misbranded A marketed device that needs a 510(k) for commercialization but failed to comply with the requirements is considered to be Misbranded. See the FD&C Act, 502(o). 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.