Question
Answer
Explanation
A medical device sponsor identifies a serious
adverse event (SAE) during a clinical trial. What
should they do?
A) Ignore it if it only happened once
B) Report it to the FDA and IRB as required
C) Stop the entire clinical trial immediate ly
D) Hide the data to prevent delays in approval
B) Report it to the FDA and IRB as required Report to FDA within 10 working days.
A medical device is undergoing an FDA 510(k)
submission, where the predicate d evice is a similar
product already on the market. The clinical trial
shows that the new device has a lower complication
rate than the predicate. What is the BEST outcome
for the FDA review?
A) The FDA will automatically approve the device
due to its improved safety profile
B) The FDA may require additional clinical trials to
prove substantial equivalence
C) The FDA will approve the device as long as the
device does not introduce new safety concerns
D) The FDA will classify the device as a Class III
device requiring PMA
C) The FDA will approve the device as long as the device
does not introduce new safety concerns
A company has developed a novel implantable
neurostimulator to treat a rare neurological disorder.
No predicate device exists, and the t echnology is
unlike any currently approved devices. The
company wants to bring this device to the U.S.
market.
Which regulatory pathway should the company
pursue, and what are the key submission
requirements they must fulfill?
A) 510(k) Premarket Notification - Demonstrate
substantial equivalence to a predicate d evice
B) PMA (Premarket Approval) - Provide valid
scientific evidence of safety and effectiveness,
including clinical data
C) De Novo Classification Request - Demonstrate
that the device is low to moderate risk and does n ot
have a predicate
D) HDE (Humanitarian Device Exemption) - Show
that the device treats a condition a ffecting fewer
than 8,000 patients per year in the U.S.
B) PMA (Premarket Approval) - Provide valid scientific
evidence of safety and effectiveness, including clinical
data
Device is Noval, No predicate so 510(k) is ruled out.
Implantable neurostimulator, high risk, thus De Novo is ruled out.
Company wants to market the product in US thus HDE is ruled out.
