Medical Technology Law Quiz Form
Test your knowledge of medical technology law. Please answer all questions below to the best of your ability.
Full Name
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First Name
Last Name
Email Address
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example@example.com
How familiar are you with medical technology regulations?
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Very familiar
Somewhat familiar
Not very familiar
Not familiar at all
Which of the following is a primary purpose of medical device regulation?
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Ensuring product safety and effectiveness
Promoting marketing for medical devices
Reducing manufacturing costs
Increasing device complexity
Select all regulatory bodies that oversee medical technology in the United States.
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Food and Drug Administration (FDA)
Federal Communications Commission (FCC)
Centers for Medicare & Medicaid Services (CMS)
National Aeronautics and Space Administration (NASA)
Other
Which law primarily governs the approval of new medical devices in the US?
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Food, Drug, and Cosmetic Act (FD&C Act)
Affordable Care Act
Health Insurance Portability and Accountability Act
Medical Technology Advancement Act
A software that controls a medical device function is classified as:
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A medical device
A general software
An accessory
A communication tool
Which of the following best describes '510(k) clearance'?
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A premarket submission to demonstrate that a device is as safe and effective as a legally marketed device
Approval for a new drug application
A process for international device sales
Certification for hospital use only
Rate your confidence in your answers to this quiz.
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Not confident
1
2
3
4
Very confident
5
1 is Not confident, 5 is Very confident
Briefly explain a recent change or challenge in medical technology law that you are aware of.
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