RAC DEVICES NEWEST PRACTICE EXAM

RAC DEVICES NEWEST PRACTICE EXAM

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QUESTIONS AND CORRECT ANSWERS

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What does the acronym IDE stand for in regulatory affairs for medical devices?

• Investigational Device Exemption
• International Device Evaluation
• Institutional Device Evaluation
• Internal Device Examination Correct Answer A) Investigational

Device Exemption

An Investigational Device Exemption (IDE) is a regulatory approval from the FDA that allows a medical device to be used in a clinical trial to collect safety and effectiveness data needed to support a premarket approval (PMA) or 510(k) submission. The IDE is crucial for conducting clinical studies and gathering the necessary evidence to demonstrate that a device is safe and effective for its intended use.

Which document provides detailed information about a medical device's design, specifications, and manufacturing processes?

• Technical File 1 / 4

• Device Master Record (DMR)
• Device History Record (DHR)
• Clinical Evaluation Report Correct Answer B) Device Master

Record

The Device Master Record (DMR) contains all the detailed information needed for the manufacturing of a medical device, including design specifications, production processes, quality assurance procedures, and labeling. It serves as a comprehensive guide for the production and control of the device to ensure consistency and compliance with regulatory requirements.

Under which regulation would a manufacturer seek approval for a new high-risk device in the U.S.?

• 510(k)
• Premarket Approval (PMA)
• De Novo Classification
• Investigational Device Exemption (IDE) Correct Answer B)

PMA

The Premarket Approval (PMA) process is required for high-risk medical devices (Class III devices) and involves providing extensive clinical data to demonstrate the device's safety and effectiveness before it can be marketed. This process is more 2 / 4

rigorous compared to the 510(k) submission or the De Novo Classification, which are typically used for lower-risk devices.

Which of the following is NOT a requirement for labeling a medical device in the U.S.?

• Manufacturer's name and address
• Intended use
• CE mark
• Instructions for use Correct Answer C) CE mark

The CE mark is a European certification that indicates a device complies with EU regulations, and it is not a requirement for labeling medical devices in the U.S. The U.S. labeling requirements include the manufacturer's name and address, intended use, and instructions for use.

What does ISO 14971 pertain to?

• Quality management systems for medical devices
• Risk management for medical devices
• Clinical trials for medical devices
• Device labeling requirements Correct Answer B) Risk

management of medical devices

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ISO 14971 is an international standard that outlines the process for identifying, evaluating, and managing risks associated with medical devices throughout their lifecycle. It provides guidelines for manufacturers to systematically assess and mitigate risks to ensure device safety and effectiveness.

Which regulatory body oversees the approval of medical devices in Japan?

A) FDA

B) PMDA

C) TGA

• Health Canada Correct Answer B) PMDA

The Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the regulatory oversight and approval of medical devices, pharmaceuticals, and other health-related products in Japan.

In the U.S., which regulation addresses electronic records and electronic signatures?

• 21 CFR Part 820
• 21 CFR Part 11
• 21 CFR Part 50
• 21 CFR Part 803 Correct Answer B) 21 CFR Part 11
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