BTC BTC Medical Device Regulations & FDA Compliance 1

Question 1

Which US federal agency is primarily responsible for regulating medical devices?

Accepted Answer

FDA (Food and Drug Administration)

Answer

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?

Accepted Answer

Class I, Class II, and Class III

Answer

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?

Accepted Answer

A premarket notification demonstrating a new device is substantially equivalent to a legally marketed predicate device

Answer

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?

Accepted Answer

Submit a Medical Device Report (MDR) to the FDA

Answer

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?

Accepted Answer

A standardized numeric or alphanumeric code identifying a device on its label, required by the FDA

Answer

The FDA's UDI system requires a standardized identifier on device labels to improve traceability, recall management, and adverse event reporting.

(BTC) Biomedical Technician Certification Practice Test

(BTC) Biomedical Technician Certification Practice Test

BTC BTC Medical Device Regulations & FDA Compliance 1