CABT Healthcare Technology and Regulations 3

Question 1

What does the term 'intended use' mean in the context of FDA medical device regulation?

Accepted Answer

The objective intent of the manufacturer as indicated in labeling and promotional materials

Answer

Intended use refers to the objective intent of the manufacturer as reflected in labeling, advertising, and promotional materials, which determines regulatory classification.

Question 2

ISO 13485 is a quality management standard specifically designed for:

Accepted Answer

Organizations in the medical device supply chain

Answer

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services.

Question 3

A hospital's biomedical department receives a Class II medical device recall notice. The FIRST action should be to:

Accepted Answer

Check the device serial numbers against the recall notice

Answer

The first step is to identify which devices on-site are affected by comparing serial/lot numbers against the recall notice before taking further action.

Question 4

Under the Safe Medical Devices Act (SMDA), which facilities are required to report device-related adverse events to the FDA?

Accepted Answer

User facilities such as hospitals and nursing homes

Answer

The SMDA requires user facilities, including hospitals and nursing homes, to report device-related deaths and serious injuries to the FDA and/or manufacturer.

Question 5

Which of the following best describes 'design validation' in medical device development under 21 CFR Part 820?

Accepted Answer

Confirming the device meets user needs and intended use through testing

Answer

Design validation confirms that the device conforms to defined user needs and intended uses, typically through real-world or simulated use testing.

(CABT) Certified Associate in Biomedical Technology Practice Test

(CABT) Certified Associate in Biomedical Technology Practice Test

CABT Healthcare Technology and Regulations 3