BTC BTC Medical Device Regulations & FDA Compliance

Question 1

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

Accepted Answer

FDA (Food and Drug Administration)

Answer

CDC

Answer

CMS

Answer

OSHA

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

Red, Yellow, Green

Answer

Level 1, Level 2, Level 3

Answer

Type A, Type B, Type C

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 Medicare billing code

Answer

An annual FDA fee payment form

Answer

A post-market surveillance report

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

Keep the information confidential

Answer

Contact the device manufacturer only

Answer

Wait until the annual audit

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 device's serial number assigned by the hospital

Answer

The insurance billing code for the device

Answer

The warranty identification number

Question 6

Which FDA regulation governs Quality System (QS) requirements for medical device manufacturers?

Accepted Answer

21 CFR Part 820 (Quality System Regulation)

Answer

21 CFR Part 110

Answer

21 CFR Part 803

Answer

21 CFR Part 50