BTC BTC Medical Device Regulations & FDA Compliance 1 — Questions and Answers
Question 1: Which US federal agency is primarily responsible for regulating medical devices?
- CDC
- FDA (Food and Drug Administration) (Correct answer)
- CMS
- OSHA
Correct answer: FDA (Food and Drug Administration)
The FDA's Center for Devices and Radiological Health (CDRH) is the primary US federal agency that regulates medical devices.
Question 2: What are the three FDA classification categories for medical devices based on risk?
- Red, Yellow, Green
- Class I, Class II, and Class III (Correct answer)
- Level 1, Level 2, Level 3
- Type A, Type B, Type C
Correct answer: Class I, Class II, and Class III
The FDA classifies medical devices as Class I (lowest risk), Class II (moderate risk), or Class III (highest risk, life-sustaining/life-supporting).
Question 3: What is a 510(k) submission?
- A Medicare billing code
- A premarket notification demonstrating a new device is substantially equivalent to a legally marketed predicate device (Correct answer)
- An annual FDA fee payment form
- A post-market surveillance report
Correct answer: A premarket notification demonstrating a new device is substantially equivalent to a legally marketed predicate device
A 510(k) premarket notification is submitted to the FDA to demonstrate that a new device is substantially equivalent to an already legally marketed predicate device.
Question 4: A biomedical technician discovers a device defect that could cause serious injury. Under FDA regulations, what must the facility do?
- Keep the information confidential
- Submit a Medical Device Report (MDR) to the FDA (Correct answer)
- Contact the device manufacturer only
- Wait until the annual audit
Correct answer: Submit a Medical Device Report (MDR) to the FDA
Under 21 CFR Part 803, healthcare facilities must submit a Medical Device Report (MDR) to the FDA when a device malfunction could cause serious injury or death.
Question 5: What does 'Unique Device Identifier' (UDI) refer to on medical devices?
- The device's serial number assigned by the hospital
- A standardized numeric or alphanumeric code identifying a device on its label, required by the FDA (Correct answer)
- The insurance billing code for the device
- The warranty identification number
Correct answer: A standardized numeric or alphanumeric code identifying a device on its label, required by the FDA
The FDA's UDI system requires a standardized identifier on device labels to improve traceability, recall management, and adverse event reporting.
Question 6: Which FDA regulation governs Quality System (QS) requirements for medical device manufacturers?
- 21 CFR Part 110
- 21 CFR Part 820 (Quality System Regulation) (Correct answer)
- 21 CFR Part 803
- 21 CFR Part 50
Correct answer: 21 CFR Part 820 (Quality System Regulation)
21 CFR Part 820, the Quality System Regulation (QSR), sets requirements for design, manufacturing, packaging, labeling, storage, and distribution of medical devices.
BTC BTC Medical Device Regulations & FDA Compliance 1
Which US federal agency is primarily responsible for regulating medical devices?