CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 1 — Questions and Answers
Question 1: Which U.S. regulatory body is responsible for classifying and overseeing medical devices used in healthcare facilities?
- FDA (Correct answer)
- CDC
- OSHA
- EPA
Correct answer: FDA
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?
- Lowest risk, subject to general controls only
- Moderate risk, subject to special controls
- Highest risk, requires premarket approval (PMA) (Correct answer)
- Exempt from FDA regulation
Correct answer: Highest risk, requires premarket approval (PMA)
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?
- Premarket Approval (PMA)
- 510(k) clearance (Correct answer)
- Humanitarian Device Exemption (HDE)
- Investigational Device Exemption (IDE)
Correct answer: 510(k) clearance
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?
- The country where the device is manufactured
- The objective intent of the manufacturer as reflected in labeling and promotional materials (Correct answer)
- The specific hospital department that purchases the device
- The sterilization method required for the device
Correct answer: The objective intent of the manufacturer as reflected in labeling and promotional materials
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.?
- World Health Organization (WHO)
- Association for the Advancement of Medical Instrumentation (AAMI) (Correct answer)
- The Joint Commission (TJC)
- Centers for Disease Control and Prevention (CDC)
Correct answer: Association for the Advancement of Medical Instrumentation (AAMI)
AAMI publishes ANSI/AAMI ST79, the comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
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?
- Simply clean and resterilize it following standard protocols
- Submit a 510(k) or equivalent application as a third-party reprocessor under FDA guidelines (Correct answer)
- Obtain written permission from the original equipment manufacturer (OEM) only
- Follow CDC guidelines without additional FDA oversight
Correct answer: Submit a 510(k) or equivalent application as a third-party reprocessor under FDA guidelines
Third-party reprocessors of SUDs must comply with FDA requirements, including submitting a 510(k) or PMA application and meeting labeling, tracking, and quality system regulations.
CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 1
Which U.S. regulatory body is responsible for classifying and overseeing medical devices used in healthcare facilities?