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Healthcare Regulation and Standards Quiz

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Healthcare Regulation and Standards Quiz

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Questions and Answers

Which federal agency is responsible for ensuring the safety and effectiveness of food, drugs, medical devices, and electronic products?

Regulatory Standards Agency

Centers for Disease Control and Prevention

Food and Drug Administration (correct)

US Department of Health and Human Services

What does a statute refer to in the context of laws and guidelines for healthcare professionals?

Comparison benchmark mandated by a governing agency

Uniform method of defining basic parameters for processes

Rules issued by administrative agencies with the force of law

Written law adopted by a legislative body (correct)

Which type of medical device is considered the most stringently regulated by the FDA?

Class 1 devices

Class 3 devices (correct)

Class 2 devices

Heart valves

What is the primary goal of the Centers for Disease Control and Prevention (CDC)?

Promoting health, quality of life, and responding to health emergencies Signup and view all the answers

What do voluntary standards in healthcare refer to?

Guidelines or recommendations for best practices Signup and view all the answers

What is the primary responsibility of the US Department of Transportation (DOT)?

Ensuring a fast, safe, and efficient transportation system Signup and view all the answers

Which organization is responsible for minimizing greenhouse gases and toxic substances?

U.S. Environmental Protection Agency Signup and view all the answers

What is the main purpose of the Occupational Safety and Health Administration (OSHA)?

Protecting workers from occupational illnesses and injuries Signup and view all the answers

Which organization is responsible for developing and promoting voluntary standards for processes and practices performed in the CSSD functions?

Association for the Advancement of Medical Instrumentation (AAMI) Signup and view all the answers

What does the CDC mandate instrument end-users to comply with?

$5(7 + 3)$ Signup and view all the answers