Class ii device - Study guides, Class notes & Summaries

CHAPTER Version A I. True or _________ 1. _________ 2. _________ 3. _________ 4. _________ 5. known as suppliers. II. Write down the letter of the answer that best answers the question or completes the statement. _________ 6. The term VFR travel refers to: A. Visiting Friends and Relatives B. Very Frequent Reservations C. Very Favorable Restrictions D. Trick question: VFR refers to nothing _________ 7. Which of the following is not a sector of the travel industry? A. Corporate t...

Multistate Pharmacy Jurisprudence(MPJE) Exam Review 2023 (FEDERAL LAW) Questions and Answers. Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products (P)FDA Correct Answer: Pure Food and Drug Act of 1906 Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA Poison Prevention Packaging Act of 1970 Correct Answer: PPPA Controlled Substance of...

What class device would a 'Drug Eluting Arterial Stent' be classified as? A) Class II device B) Class I device C) Class III device D) Class IV device Correct Answer-D) Class IV device A suitable staining agent for a blood smear is: A) Gram's Stain B) Masson's Trichrome Stain C) H&E Stain D) Wright's Stain Correct Answer-D) Wright's Stain In the context of biomaterials, the FDA regulates: A) Metals and Polymers B) Ceramics and Polymers C) Any material invented in a lab and ...

Florida MPJE: June 2023 Questions and Answers 100% correct Food, Drug, and Cosmetic Act of 1938 Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising ...

Indiana MPJE Exam Review Questions 2022/2023 | Consisting Of 111 Questions With Verified Answers From Experts Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful material...

EBME 306 Final Multiple Choice Questions & Answers 100% Correct EBME 306 Final Multiple Choice Questions & Answers 100% Correct EBME 306 Final Multiple Choice Questions & Answers 100% Correct EBME 306 Final Multiple Choice Questions & Answers 100% Correct EBME 306 Final Multiple Choice Questions & Answers 100% Correct What class device would a 'Drug Eluting Arterial Stent' be classified as? A) Class II device B) Class I device C) Class III device D) Class IV device - ANSWERD) Class IV de...

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report - Answer A During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical inv...

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Define biomaterial Correct Answer-Any substance, other than a drug, or combination of substances, synthesized or natural in origin which can be used for any period of time, as a whole or part of the system, which treats, augments, or replaces any tissue organ or function of the body. (is in contact with living tissue) (contact lens vs eye glasses) OR a synthetic or natural material that is used to replace part of a living system or to function in intimate contact with living tissue What is ...

CRCST Exam Questions and Answers 100% CorrectCRCST Exam Questions and Answers 100% CorrectCRCST Exam Questions and Answers 100% CorrectCRCST Exam Questions and Answers 100% CorrectCRCST Exam Questions and Answers 100% Correct Classification for Sterilization Packaging - ANSWER-Class II Medical Devices (those presenting a potential risk) Packaging used for steam sterilization must be capable of withstanding high temperatures of? - ANSWER-250'F - 275'F (121'C - 135'C) Process in which a...