CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 1

Question 1

Which U.S. regulatory body is responsible for classifying and overseeing medical devices used in healthcare facilities?

Accepted Answer

FDA

Answer

The Food and Drug Administration (FDA) classifies and regulates medical devices in the United States.

Question 2

A Class III medical device is characterized by which of the following?

Accepted Answer

Highest risk, requires premarket approval (PMA)

Answer

Class III devices pose the highest risk to patients and require FDA Premarket Approval (PMA) before marketing.

Question 3

Which FDA submission pathway is typically used for moderate-risk Class II medical devices?

Accepted Answer

510(k) clearance

Answer

Class II devices generally require 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device.

Question 4

What does the term 'intended use' mean in the context of medical device regulation?

Accepted Answer

The objective intent of the manufacturer as reflected in labeling and promotional materials

Answer

Intended use refers to the objective intent of the person legally responsible for labeling, including any conditions of use described in the labeling.

Question 5

Which organization publishes standards such as ANSI/AAMI ST79 that guide sterile processing practices in the U.S.?

Accepted Answer

Association for the Advancement of Medical Instrumentation (AAMI)

Answer

AAMI publishes ANSI/AAMI ST79, the comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

CMDRT - Certified Medical Device Reprocessing Technician Practice Test

CMDRT - Certified Medical Device Reprocessing Technician Practice Test

CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 1