FDA ICE

Which of the following is NOT within the FDA’s mission to ensure the safety and effectiveness of?

• medical devices

• Animal feed and veterinary drugs

• Meat and poultry products

• Radiation-emitting products

Meat and poultry products

Which of the following is part of the FDA’s mission to promote and protect public health?

• regulating vaccines and blood products

• overseeing the safety of cosmetics (except soap and shampoo)

• Ensuring the safety and effectiveness of prescription drugs

• All of the above

all of the above

Before the establishment of the FDA, what was the primary system for regulating domestic products in the united states during the 18th and 9th centuries?

• federal agencies were responsible for regulating both domestic and imported products

• states were responsible for regulating domestic products, while the federal government oversaw imports

• no regulations existed for either domestic or imported products

• regulation was handled exclusively by private organizations

States were responsible for regulating domestic products, while the federal government oversaw imports

which of the following statements about Harvey w Wiley, one of the key figures in the origin of the FDA, is true?

• He taught the first chemistry course in Indiana in 1873

• He was a professor a Purdue University starting in 1874

• He published his first paper in 1881 on detecting glucose dilution in cane sugar

• all of the above

all of the above

Which of the following was a provision of the Pure Food and Drugs Act in 1906?

• It prohibited the interstate transport of adulterated or misbranded food and drugs

• product labels could not be false or misleading, but pre-market approval was not required

• manufactures had to list 11 dangerous ingredients, such as alcohol, heroin, and cocaine, if used in the product

• all of the above

all of the above

In which year did the US Food and Drug Administration’s role in the regulation of novel medicines become established?

• 1906

• 1927

• 1938

• 1976

1938

after what year was pre-market approval required for new(post-amendment) devices?

• 1906

• 1927

• 1938

• 1976

1976

which of the following are responsibilities of the FDA regarding medical devices?

• evaluate new devices for marketing

• monitor devices already on the market

• act against firms that violate the law

• Perform research on devices and develop standard testing methods

• Educate professionals and consumers on safe use of devices

• all of the above

all of the above

Which of the following is true about the 510(k) premarket notification process for medical devices?

• it requires clinical trials for all devices

• it allows FDA to determine substantial equivalence (SE) to a device already on the market

• it is only applicable to high-risk devices

• it is a post-market approval process for devices

It allows FDA to determine substantial equivalence (SE) to a device already on the market

A device is considered substantially equivalent (SE) to a legally marketed device if it:

• has the same intended use and does not raise new questions of safety and effectiveness

• has the same technological characteristics but does not need to demonstrate equal safety and effectiveness

• has a different intended use but similar technological characteristics

• raises new questions of safety and effectiveness while demonstrating equal safety and effectiveness

has the same intended use and does not raise new questions of safety and effectiveness

Which of the following statements about Class I medical devices is correct?

A) All Class I devices require premarket approval before marketing

B) Class I devices have the highest risk and need extensive clinical testing

C) Most Class I devices (95%) are exempt from review due to their extremely low risk or similarity to existing devices

D) Class I devices must demonstrate substantial equivalence (SE) to other devices on the market

Most Class I devices (95%) are exempt from review due to their extremely low risk or similarity to existing devices

Which of the following is true about Class III medical devices?

A) Class III devices are low-risk and are often exempt from premarket approval

B) Class III devices include those that are life-sustaining or life-supporting and present a higher risk to patient health

C) Class III devices are typically exempt from FDA review due to their similarity to existing devices

D) Class III devices account for 47% of all medical devices

Class III devices include those that are life-sustaining or life-supporting and present a higher risk to patient health

Which of the following is NOT an action the FDA can take against firms that violate the law

regarding medical devices?

A) Enjoining the firms

B) Withdrawing the investigational device exemption

C) Seizing the devices

D) Offering financial incentives to encourage compliance

Offering financial incentives to encourage compliance