29 Questions
Which of the following is NOT considered a device under the official definition?
X-ray film
What is the best representation of 'fair balance' in advertising?
Risks and benefits are presented in comparable prominence, readability
When is an Investigational New Drug (IND) not required?
You intend to collect blood samples to look for biomarkers or pharmacogenetic information
What is NOT required before starting a Non-Significant Risk device clinical trial?
Submission of the trial protocol to FDA for approval
How often should employees receive training in Good Manufacturing Practices (GMPs)?
On a biennial basis
Which of the following situations would require an Investigational New Drug (IND)?
Conducting a clinical trial with an approved drug for a new indication
Which of the following activities is not required for GLP study directors?
Approving the final study reports
A non-powered microsurgical instrument used in neurological microsurgery procedures is classified as which type of medical device?
Class 1
If a regulatory affairs professional receives a warning letter from DDMAC regarding direct-to-consumer (DTC) advertising, what should be the first action taken?
Cease dissemination of violative materials
According to the regulations, which group is not required to notify the FDA if they become aware of reportable information?
Distributors
Which of the following is the definition of a label according to the regulations?
Affixed to the immediate container
For which of the following situations should management NOT be notified in writing of GMP investigations conducted?
Batch production record documentation corrections
Which class of device is a male condom classified under?
Class 2
What is the classification of non-prescription sunglasses?
Class 1
Which of the following scenarios does not meet the definition of adulteration?
Incorrect lot number on the label
According to the Federal Food, Drug and Cosmetics (FD&C) Act, which of the following is not part of the definition of a drug?
Devices or their components
Which term best describes Design Inputs according to the QSR?
What is typically included in a reminder advertisement?
Brand and generic names
How should ADEs (Adverse Drug Events) that do not meet 15-day reporting requirements be reported by the applicant?
Quarterly for 3 years after application is approved, annually thereafter, unless an alternate arrangement is required by FDA
What does the Quality Systems Inspection Technique focus on?
Management
What information is NOT typically included in a reminder advertisement?
Dosage instructions
Which of the following statements is true?
Applicants must report ADEs not meeting 15-day reporting requirements quarterly for 3 years after approval
Which of the following is NOT mentioned in the text as a focus area of the Quality Systems Inspection Technique?
Marketing and Advertising
Which of the following devices requires a Premarket Notification (510(k))?
A device not equivalent to currently marketed devices
According to the Quality System Regulation (QSR), which of the following is a requirement for Quality Audits?
Evaluate if the Quality System is in compliance with the QSR
The Quality System Regulation (QSR) applies to the manufacturing of which of the following?
Finished devices and accessories to finished devices
Which of the following is required to be included in the Device Master Record (DMR)?
All of the packaging and labeling associated with the finished device
How often must a manufacturer submit periodic reports after a Premarket Notification (510(k)) application is approved?
Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA
Which of the following statements is true regarding the Quality System Regulation (QSR)?
It requires Quality Audits to evaluate compliance with the QSR and determine the effectiveness of the Quality System
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.
Test your knowledge on FDA regulations and Good Manufacturing Practice (GMP) investigations with this quiz. Questions cover topics such as reporting drug product complaints, handling returned drug products, and notifying management of investigations. See how well you understand these important pharmaceutical industry requirements.
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