Rac exam practice 2024 - Study guides, Class notes & Summaries

RAC Practice Exam 1(2024) Questions With 100% Correct Answers.

RAC 2016 US RAC Practice Exam 2024 | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ 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. - Explanation: B. T...

RAC PRACTICE EXAM UPDATE 2024/2025 WITH QUESTIONS AND CORRECT VERIFIED ANSWERS GRADE A

RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expir...

RAC Devices Practice Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified

The opening inside the skull that holds the brain is the: a. Cranial cavity b. Orbital cavity c. Nasal cavity d. Thoracic cavity - ANSWER-*The dorsal cavity is divided into the cranial cavity (which houses the brain) The answer is: Cranial cavity A crime punishable by a fine or imprisonment for less than one year is known as a: a. Misdemeanor b. Arbitration c. Felony d. Mitigation - ANSWER-*Misdemeanors are less serious crimes than felonies and re punishable by fines or imprisonment ...

RAC Exam Practice Exam 2024 with complete solution Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - Answer ️️ -A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver- Harri...

2024 RAC Practice Exam | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

RAC Practice Exam 1 Latest 2024 with complete solution Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Est...