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Questions and Answers

Which of the following is NOT considered a device under the official definition?

  • Eyeglass lenses and frames
  • Sterilizers used for device manufacturing
  • X-ray film (correct)
  • In vitro diagnostic kit
  • What is the best representation of 'fair balance' in advertising?

  • Established name appears next to brand name in type at least 50% of brand name
  • Risks and benefits are presented in comparable prominence, readability (correct)
  • A reminder ad
  • Advertising directed to physicians and consumers
  • When is an Investigational New Drug (IND) not required?

  • You intend to collect blood samples to look for biomarkers or pharmacogenetic information (correct)
  • You intend to conduct a clinical trial with an approved drug for a new indication
  • You intend to conduct a clinical trial using 2 approved drugs in a new combination
  • You intend to conduct a clinical trial with an investigational new drug
  • What is NOT required before starting a Non-Significant Risk device clinical trial?

    <p>Submission of the trial protocol to FDA for approval</p> Signup and view all the answers

    How often should employees receive training in Good Manufacturing Practices (GMPs)?

    <p>On a biennial basis</p> Signup and view all the answers

    Which of the following situations would require an Investigational New Drug (IND)?

    <p>Conducting a clinical trial with an approved drug for a new indication</p> Signup and view all the answers

    Which of the following activities is not required for GLP study directors?

    <p>Approving the final study reports</p> Signup and view all the answers

    A non-powered microsurgical instrument used in neurological microsurgery procedures is classified as which type of medical device?

    <p>Class 1</p> Signup and view all the answers

    If a regulatory affairs professional receives a warning letter from DDMAC regarding direct-to-consumer (DTC) advertising, what should be the first action taken?

    <p>Cease dissemination of violative materials</p> Signup and view all the answers

    According to the regulations, which group is not required to notify the FDA if they become aware of reportable information?

    <p>Distributors</p> Signup and view all the answers

    Which of the following is the definition of a label according to the regulations?

    <p>Affixed to the immediate container</p> Signup and view all the answers

    For which of the following situations should management NOT be notified in writing of GMP investigations conducted?

    <p>Batch production record documentation corrections</p> Signup and view all the answers

    Which class of device is a male condom classified under?

    <p>Class 2</p> Signup and view all the answers

    What is the classification of non-prescription sunglasses?

    <p>Class 1</p> Signup and view all the answers

    Which of the following scenarios does not meet the definition of adulteration?

    <p>Incorrect lot number on the label</p> Signup and view all the answers

    According to the Federal Food, Drug and Cosmetics (FD&C) Act, which of the following is not part of the definition of a drug?

    <p>Devices or their components</p> Signup and view all the answers

    Which term best describes Design Inputs according to the QSR?

    Signup and view all the answers

    What is typically included in a reminder advertisement?

    <p>Brand and generic names</p> Signup and view all the answers

    How should ADEs (Adverse Drug Events) that do not meet 15-day reporting requirements be reported by the applicant?

    <p>Quarterly for 3 years after application is approved, annually thereafter, unless an alternate arrangement is required by FDA</p> Signup and view all the answers

    What does the Quality Systems Inspection Technique focus on?

    <p>Management</p> Signup and view all the answers

    What information is NOT typically included in a reminder advertisement?

    <p>Dosage instructions</p> Signup and view all the answers

    Which of the following statements is true?

    <p>Applicants must report ADEs not meeting 15-day reporting requirements quarterly for 3 years after approval</p> Signup and view all the answers

    Which of the following is NOT mentioned in the text as a focus area of the Quality Systems Inspection Technique?

    <p>Marketing and Advertising</p> Signup and view all the answers

    Which of the following devices requires a Premarket Notification (510(k))?

    <p>A device not equivalent to currently marketed devices</p> Signup and view all the answers

    According to the Quality System Regulation (QSR), which of the following is a requirement for Quality Audits?

    <p>Evaluate if the Quality System is in compliance with the QSR</p> Signup and view all the answers

    The Quality System Regulation (QSR) applies to the manufacturing of which of the following?

    <p>Finished devices and accessories to finished devices</p> Signup and view all the answers

    Which of the following is required to be included in the Device Master Record (DMR)?

    <p>All of the packaging and labeling associated with the finished device</p> Signup and view all the answers

    How often must a manufacturer submit periodic reports after a Premarket Notification (510(k)) application is approved?

    <p>Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA</p> Signup and view all the answers

    Which of the following statements is true regarding the Quality System Regulation (QSR)?

    <p>It requires Quality Audits to evaluate compliance with the QSR and determine the effectiveness of the Quality System</p> Signup and view all the answers

    Study Notes

    Device Classification and Definition

    • Under the official definition of a "device", all of the following are considered devices except X-ray film.
    • Eyeglass lenses and frames are considered devices.
    • Sterilizers used for device manufacturing are considered devices.

    Clinical Trials and IND

    • An IND (Investigational New Drug) is not required when conducting a clinical trial with an approved drug to collect blood samples from subjects to look for biomarkers or pharmacogenetic information.
    • An IND is required when conducting a clinical trial with an investigational new drug, or when conducting a clinical trial with an approved drug to support a marketing application for a new indication.
    • An IND is required when conducting a clinical trial using 2 of your approved drugs in a new combination.

    GMP and Training

    • Employees should receive training in GMPs on a continuing basis.
    • Management should be notified in writing of GMP investigations conducted for all of the following except Batch Production Record documentation corrections.

    Post-Marketing Surveillance

    • The MDR (Medical Device Reporting) regulations require that manufacturers, distributors, and user facilities notify FDA if they become aware of information required to be reported.
    • Distributors are not required to notify FDA if they become aware of information required to be reported.

    Labeling and Advertising

    • A label is defined as that which is affixed to the immediate container.
    • A reminder advertisement typically includes the brand and generic names.
    • Risks and benefits should be presented in comparable prominence, readability, and in a fair balance.

    Device Classification

    • A non-powered microsurgical instrument for use in neurological microsurgery procedures is an example of a Class 1 device.
    • A male condom is an example of a Class 2 device.
    • Non-prescription sunglasses are an example of a Class 1 device.

    FDA Inspections and Audits

    • The Quality Systems Inspection Technique (QSIT) focuses on management.
    • GLP (Good Laboratory Practice) study directors are required to conduct activities except approving the final study reports.
    • Quality Audits must evaluate if the Quality System is in compliance with the QSR (Quality System Regulation) and determine the effectiveness of the Quality System.

    Adulteration and Misbranding

    • A bottle of aspirin that is not packaged in tamper-resistant packaging is an example of adulteration.
    • A drug recognized in the USP/NF that does not meet all compendium standards is an example of adulteration.
    • Incorrect lot number on the label is not an example of adulteration.

    Quality System Regulation

    • The QSR pertains to the manufacturing of finished devices, components, and accessories to finished devices.
    • Design Inputs are best described as the performance requirements that the product must meet.
    • Quality Audits must accomplish evaluating if the Quality System is in compliance with the QSR and determining the effectiveness of the Quality System.

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