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RAC Exam Study Guide with Complete Solutions drug - Correct Answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Correct Answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...

AMCA-MAC Exam Study Guide Questions and Answers (latest Update 2024)

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 - 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...

What drug enhances the effect of another drug: (Ans- synergistic The normal volume of urine produced by an adult in 24 hour period generally does not exceed: (Ans- 2000mL A 24 hour specimen would be an example of a: (Ans- Time Specimen What is the name of the law that protects health care workers who give aid during the time of an accident: (Ans- Good Samaritan Law All pathogens are (Ans- microbes that can cause disease Two employees discussing a patient diagnosis on a h...

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