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

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

Answer: FDA

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

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

Answer: Highest risk, requires premarket approval (PMA)

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

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

Answer: 510(k) clearance

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

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

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.

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

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.

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

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.