Misbranded device - Study guides, Class notes & Summaries

MPJE – Michigan Questions and Answers Graded A+ Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable Misbranded Adulte...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510...

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 ...

Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - correct answer C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology o...

Misbranding - correct answer Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling - correct answer Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - correct answer Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable - correct a...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - correct answer C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B....

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...

MPJE - MichiganMisbranding - correct answer Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or misbranded? False/misleading labeling - correct answer Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - correct answer Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readab...

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 ...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510...