CABT Healthcare Technology and Regulations 2

Question 1

Which FDA classification requires the most stringent premarket approval process for medical devices?

Accepted Answer

Class III

Answer

Class III devices require Premarket Approval (PMA) because they sustain or support life or present a potential unreasonable risk of illness or injury.

Question 2

Under HIPAA, a Business Associate Agreement (BAA) is required when a third-party vendor does which of the following?

Accepted Answer

Creates, receives, maintains, or transmits PHI on behalf of a covered entity

Answer

A BAA is required whenever a vendor handles Protected Health Information (PHI) on behalf of a HIPAA-covered entity.

Question 3

The primary purpose of the 510(k) premarket notification process is to demonstrate that a new device is:

Accepted Answer

Substantially equivalent to a legally marketed predicate device

Answer

The 510(k) pathway requires demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.

Question 4

Which standard specifically governs electromagnetic compatibility (EMC) requirements for medical electrical equipment in the US?

Accepted Answer

IEC 60601-1-2

Answer

IEC 60601-1-2 is the collateral standard addressing electromagnetic disturbances requirements for medical electrical equipment.

Question 5

A biomedical technician discovers that a ventilator has caused a patient injury. Under FDA MDR regulations, the hospital must report this event within:

Accepted Answer

30 calendar days, or 5 working days if remedial action was taken

Answer

FDA MDR regulations require user facilities to report device-related deaths or serious injuries to FDA within 30 days, or 5 working days if remedial action was taken.

(CABT) Certified Associate in Biomedical Technology Practice Test

(CABT) Certified Associate in Biomedical Technology Practice Test

CABT Healthcare Technology and Regulations 2