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 I

Answer

Class II

Answer

Class IV

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

Sells medical equipment to a hospital

Answer

Provides general IT support with no access to patient data

Answer

Manufactures pharmaceutical supplies

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

Safe and effective through clinical trials

Answer

Classified as Class I exempt from regulation

Answer

Approved for international distribution

Question 4

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

Accepted Answer

IEC 60601-1-2

Answer

ANSI/AAMI ES60601-1

Answer

ISO 13485

Answer

UL 2601-1

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

5 working days for serious injury

Answer

10 working days for all adverse events

Answer

60 calendar days

Question 6

Which regulatory body oversees the accreditation of healthcare organizations in the United States and evaluates compliance with safety standards?

Accepted Answer

The Joint Commission (TJC)

Answer

CMS

Answer

OSHA

Answer

FDA

Question 7

An IFU (Instructions for Use) for a medical device must be provided in which language for devices sold in the United States?

Accepted Answer

English only

Answer

English and Spanish

Answer

English and any language spoken by more than 5% of the local population

Answer

English, with translations required if the device is sold in multilingual markets