Us rac exam Study guides, Class notes & Summaries

RAC Exam - Devices US (Answered) Correctly!!

Administrative Chain of Command 1. POTUS 2. SECDEF 3. SECNAV 4. CNO ☆☆☆☆ 5. PACFLT/USFF ☆☆☆☆ 6. TYCOM ☆☆ or ☆☆☆ 7. DESRON/PHIBRON 8. CO Operational Chain of Comand 1. POTUS 2. SECDEF 3. CJCS ☆☆☆☆ 4. COCOM ☆☆☆☆ 5. FLT COMMANDER ☆☆☆☆ 6. CSG/ESG ☆ 7. DESRON/PHIBRON 8. CO USPACOM (COCOM) Indo-Asia-Pacific Region Based in Honolulu, HI USCENTCOM (COCOM) Middle East, Central Asia, Egypt Based in Macdill AFB, FL ...

[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]...

2023 US RAC Practice Exam Questions With Correct Explanations 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. There are no 15 day reports included in MDR regulations....

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - correct answer C) You intend to collect blood sampl...

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 ...

APEA 3P EXAM PREP3 –NEPHROLOGY WITH RATIONALE A hea l thy 32-year-o l d female has le f t f l ank pa in and nausea. What is the most l i ke ly d iagnos is? Ur inary t rac t in fec t i on Rena l s tone Cholecys t i t i s Pye lonephr i t i s The most common presenta t ion o f acu te uncompl ica ted pye lonephr i t i s inc ludes fever , f lank pa in , and nausea and vomi t i ng. Somet imes pat ient s p resent w i th symptoms o f pe lv ic i nf lammatory d isease (PID) . In th is p re...

Division Officer Fundamentals Review Exam 183 Questions with Verified Answers SORM - CORRECT ANSWER Standard Organization Regulations Manual What does the SORM do? - CORRECT ANSWER outlines standard Navy Organization, dictates required ship bills and instructions, and enables personnel to transfer from ship to ship How many Unified Commands are there? - CORRECT ANSWER 6 USEUCOM - CORRECT ANSWER European Command (Stuttgart, Germany) USCENTCOM - CORRECT ANSWER Central Command (MacDi...

US RAC Latest 2023 Practice Exam Questions with Complete Answers (Graded A+)