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

Question 1

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

Accepted Answer

FDA

Answer

CDC

Answer

OSHA

Answer

EPA

Question 2

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

Accepted Answer

Highest risk, requires premarket approval (PMA)

Answer

Lowest risk, subject to general controls only

Answer

Moderate risk, subject to special controls

Answer

Exempt from FDA regulation

Question 3

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

Accepted Answer

510(k) clearance

Answer

Premarket Approval (PMA)

Answer

Humanitarian Device Exemption (HDE)

Answer

Investigational Device Exemption (IDE)

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

The country where the device is manufactured

Answer

The specific hospital department that purchases the device

Answer

The sterilization method required for the device

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

World Health Organization (WHO)

Answer

The Joint Commission (TJC)

Answer

Centers for Disease Control and Prevention (CDC)

Question 6

A single-use device (SUD) is labeled 'Do Not Reuse.' What must a facility do if it intends to reprocess and reuse the device?

Accepted Answer

Submit a 510(k) or equivalent application as a third-party reprocessor under FDA guidelines

Answer

Simply clean and resterilize it following standard protocols

Answer

Obtain written permission from the original equipment manufacturer (OEM) only

Answer

Follow CDC guidelines without additional FDA oversight