52 - 61

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.