CABT Healthcare Technology and Regulations 3 — Questions and Answers
Question 1: What does the term 'intended use' mean in the context of FDA medical device regulation?
- How a device is physically designed to operate
- The objective intent of the manufacturer as indicated in labeling and promotional materials (Correct answer)
- The clinical outcomes achieved in trials
- The device's country of manufacture
Correct answer: The objective intent of the manufacturer as indicated in labeling and promotional materials
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:
- General manufacturing industries
- Organizations in the medical device supply chain (Correct answer)
- Hospital infection control programs
- Clinical laboratory operations
Correct answer: Organizations in the medical device supply chain
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:
- Immediately remove all affected devices from service
- Notify the FDA directly
- Check the device serial numbers against the recall notice (Correct answer)
- Contact the manufacturer for a replacement
Correct answer: Check the device serial numbers against the recall notice
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?
- Only device manufacturers
- Manufacturers and importers only
- User facilities such as hospitals and nursing homes (Correct answer)
- Only outpatient clinics and ambulatory surgery centers
Correct answer: User facilities such as hospitals and nursing homes
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?
- Confirming that device design outputs meet design inputs
- Confirming the device meets user needs and intended use through testing (Correct answer)
- Verifying that software code is free of errors
- Ensuring manufacturing processes are documented
Correct answer: Confirming the device meets user needs and intended use through testing
Design validation confirms that the device conforms to defined user needs and intended uses, typically through real-world or simulated use testing.
Question 6: A CBET notices a patient monitor displaying erratic readings after a nearby surgical cautery unit is activated. This interference is best categorized as:
- Conducted emissions
- Radiated susceptibility (immunity failure) (Correct answer)
- Electrostatic discharge
- Common-mode noise
Correct answer: Radiated susceptibility (immunity failure)
When a device malfunctions due to electromagnetic energy radiated from a nearby source, this is a radiated susceptibility or immunity failure.
Question 7: Which federal law established the framework for regulating health information technology and incentivizing adoption of electronic health records (EHRs)?
- HIPAA (1996)
- HITECH Act (2009) (Correct answer)
- Affordable Care Act (2010)
- FDA Safety and Innovation Act (2012)
Correct answer: HITECH Act (2009)
The HITECH Act of 2009 established programs to incentivize meaningful use of EHRs and strengthened HIPAA privacy and security enforcement.
CABT Healthcare Technology and Regulations 3
What does the term 'intended use' mean in the context of FDA medical device regulation?