FDA - Devices

Question 1

What does FDA stand for?

Answer 1

Food and Drug Administration

Question 2

True or False: The FDA is responsible for regulating medical devices in the United States.

Answer 2

True

Question 3

What are the three categories of medical devices according to the FDA?

Answer 3

Class I, Class II, and Class III

Question 4

Fill in the blank: Class ____ devices are considered low risk and are subject to the least regulatory control.

Answer 4

I

Question 5

Which class of medical devices requires premarket approval?

Answer 5

Class III

Question 6

What is the primary purpose of the 510(k) submission?

Answer 6

To demonstrate that a device is substantially equivalent to a legally marketed device.

Question 7

True or False: All medical devices must undergo clinical trials before they can be marketed.

Answer 7

False

Question 8

What is PMA in the context of FDA device regulation?

Answer 8

Premarket Approval

Question 9

Multiple choice: Which of the following is NOT a requirement for Class II devices? A) 510(k) submission B) Premarket Approval C) Performance standards

Answer 9

B) Premarket Approval

Question 10

What is the role of the FDA’s Center for Devices and Radiological Health (CDRH)?

Answer 10

To regulate and ensure the safety and effectiveness of medical devices.

Question 11

Fill in the blank: The FDA’s ‘de novo’ classification process is used for devices that are considered ____ and have no predicate.

Answer 11

novel

Question 12

True or False: Class III devices are usually life-sustaining or life-supporting.

Answer 12

True

Question 13

What is the significance of the ‘predicate device’ in the 510(k) process?

Answer 13

It serves as a benchmark for establishing substantial equivalence.

Question 14

Multiple choice: Which class of devices is most likely to require clinical studies for approval? A) Class I B) Class II C) Class III

Answer 14

C) Class III

Question 15

What is the purpose of the FDA’s post-market surveillance?

Answer 15

To monitor the safety and effectiveness of devices after they are on the market.

Question 16

Fill in the blank: A medical device that is intended to be implanted in the body for more than ____ days is classified as Class III.

Answer 16

30

Question 17

True or False: The FDA can recall a medical device if it poses a risk to health.

Answer 17

True

Question 18

What is the difference between a Class I and Class II medical device?

Answer 18

Class I devices are low risk and subject to general controls, while Class II devices require additional regulatory controls.

Question 19

What is an example of a Class I device?

Answer 19

Bandages

Question 20

What is an example of a Class III device?

Answer 20

Pacemakers

Question 21

Fill in the blank: The FDA’s Good Manufacturing Practices (GMP) are regulations that govern the ____ of medical devices.

Answer 21

manufacturing

Question 22

True or False: All medical devices must include labeling that provides adequate directions for use.

Answer 22

True

Question 23

What is the purpose of the FDA’s Unique Device Identification (UDI) system?

Answer 23

To improve the identification and traceability of medical devices.

Question 24

Multiple choice: Which of the following is a requirement for premarket approval (PMA)? A) Risk assessment B) Clinical data C) 510(k) submission

Answer 24

B) Clinical data

Question 25

What does the term ‘substantial equivalence’ mean in FDA regulations?

Answer 25

It means the new device is as safe and effective as a legally marketed device.

Question 26

Fill in the blank: The FDA holds the authority to impose ____ on manufacturers who violate regulations.

Answer 26

penalties