1 / 17

RAC US Dumps with 100% passing guarantee

Now pass RAPS Certification RAC US Exam in the first attempt with the help of Exams4sure.co. <br>Exams4sure the name of superior quality and approved dumps. <br>Get RAC US Dumps with 100% passing guarantee. <br>We provide you RAC US Exam Questions compiled by the RAC US Experts. <br>Visit us today and get 40% discount on RAC US Braindumps. <br>Our chat support will help 24/7.<br>https://www.exams4sure.co/RAPS/RAC-US-dumps.html

rogerjones43
Download Presentation

RAC US Dumps with 100% passing guarantee

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Want to Know How to Pass RAC US Exam?

  2. Yea you are Right it's difficult to study along with job Study Along with Job really Tough for me nowdays Don't worry guy's try Exams4sure. I prepare my RAC US exam by Exams4sure PDF and Test Engine & I’ll got 87% in first attempt. !??

  3. Exams4sure one of the Leading Brand in IT Certification & Also providing 3500+ Certification Accurate Questions & Answers. You can also try Exams4sure RAC US Test Engine Real Exam Mode it will reduce your exam anxiety. Let's go and prepare for the RAC US Final Exam https://www.exams4sure.co/RAPS/RAC-US-dumps.html

  4. Question No 1: 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. Answer: C

  5. Question No 2: Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT: A. A deviation from the investigational plan. B. Withdrawal of IRB approval. C. An unanticipated adverse device effect. D. Use of a device without informed consent. Answer: C

  6. Question No 3: When design verification testing is being performed by a manufacturer, which element is NOT included as a potential requirement under device design verification section of the QSR? A. Identification of the design B. Software validation C. Identification of test methods used. D. Name of individuals performing the testing . Answer: C

  7. Question No 4: Under the statutory violations, lack of an approved PMA for a PMA device that is not exempt and is in commercial distribution is considered to be: A. Adulteration. B. Improper use. C. Misbranded. D. Fraudulent. Answer: A

  8. Question No 5: A manufacturer of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time. B. A device intended solely for veterinary use. C. A custom device being studied for safety and effectiveness. D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time. And a device intended solely for veterinary use. Answer: C

  9. Question No 6: The regulatory affairs professional performs all of the following prior to submitting a PMA to FDA EXCEPT: A Preparing criteria for the MDR report. B. Preparing a brief statement of reasons for noncompliance with regulation. C. Identifying all omissions in PMA content. D. Reviewing, organizing and checking adequacy of data pertaining to safety and efficacy evaluation. Answer: A

  10. Question No 7: Which of the following sections is required in a PMA? A. Patent certification information. B. A copy of quality manual. C. An economic cost/benefit assessment. D. A discussion of benefit and risk considerations. Answer: D

  11. Question No 8: Subacute toxicity testing should be performed: A. In two rodent species. B. In one rodent and one non-rodent species. C. For a minimum of two weeks. D. For a minimum of six months. Answer: B

  12. Question No 9: What FDA clearances are required to export a drug approved by FDA? A. Certificate of Free Sale. B. Customs Tax Stamps. C. No clearance required. D. FDA receipt for sample Form-484. Answer: C

  13. Question No 10: Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. However, finalized and fully quality assured reports should be available to FDA upon request within what period of the start of the human study? A 90 days. B. 120 days. C. One year. D. The final report is only required in the submission for the NDA Answer: B

  14. Why Choose Exams4sure? RAC US Accurate Questions Answers Real Exam Questions Simulations 100% Passing Assurance 100% Money Back Guarantee 3 Months Free Updates https://www.exams4sure.co/RAPS/RAC-US-dumps.html

  15. GET OFFER!

  16. Pass your rac us exam in 1 day by the help of Exams4sure. Get Special Discount by using this Coupon Code “XEY20” https://www.exams4sure.co/RAPS/RAC-US-dumps.html

More Related