Us rac practice exam - Study guides, Class notes & Summaries

US RAC Practice Exam Questions With 100% Correct Answers [Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - Answer-[A] Agreement meeting /.[Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed? [A] Type A [B] Type B [C] Ty...

US RAC Latest 2023 Practice Exam Questions with Complete Answers.

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - correct answer [A] Agreement meeting [Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed? [A] Type A [B] Type B [C] Type C [D] Type D - correct answer [A] Type A [Q]...

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. - correct answer Explanation: B. There are no 15 day reports included in MDR regulations. 15 Day reports are required b by drug reporting ...

US RAC PRACTICE EXAM-XW WITH VERIFIED SOLUTIONS.

RAC Practice Exam 2 -HJ Questions & Answers You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the USbased medical device company (Company B) for final assembly. Which company needs to register with FDA: A. Company A B. Company B C. Company A &B D. Compa...

CPMA practice exam A Questions and Answers 100% Correct 2023 SOAP Subjective, Objective, Assessment, Plan CHEDDAR Chief complaint, Hx, Exam, Details of problem/complaint, Drugs & dosages, Assessment, Return visit Subjective Pt complaint Objective Provider observation Assessment Medical Dx Plan Treatment You are performing an audit of e/m services for a FP office. In the encounter you read the physician ordered and reviewed a differential WBC. What...

Aptive smoke screens/objections Exam Practice Questions and Answers "No thanks, i'm not interested"/I'm good - Answer️️ -"sure, most of the homes I'm taking care of aren't seeing many bugs on the inside yet either. It's mostly been on the outside with the spiders and the ants. What I'm doing for the neighbors is... (go to price) "I'm not seeing anything/no bugs" - Answer️️ -"sure, it is early in the season. What I am doing is the preventative work on the exterior that ...