Question
Answer
Explanation
Under the FDA's QSR (Quality System Regulations), which of
the following must be implemented for a medical device
manufacturer?
A. Clinical trials for all devices
B. A validated system for design control
C. An annual review by the FDA
D. Pre-market clinical trials
What does the term "substantial equivalence" refer to in the
context of FDA 510(k) submissions?
A. A new device that is identical to an exis ting device
B. A new device that is similar in int ended use and performance
to a legally marketed device
C. A device that meets all FDA safety requirements
D. A device that is more effective than a legally marketed
device
Which of the following documents is required for a Premarket
Approval (PMA) submission?
A. 510(k)
B. Design History File (DHF)
C. Clinical Data Study Protocol
D. Annual Report
A startup has created an implantable cardi ac device that
provides real-time electrochemical monitoring of heart function.
The technology is entirely new, and no predicate device exists.
The device is classified as Class III due to its high-risk nature.
What is the most appropriate premarket sub mission for this
device?
A) 510(k)
B) PMA
C) De Novo
D) IDE
B) PMA Why not IDE? IDE will be requitred to generate
clinical data for this PMA.
A company develops a wearable sensor that monitors hydration
levels in real-time and provides alerts to prevent dehydration.
The device has no existing predicate, bu t the company believes
it poses low to moderate risk and does not meet the crit eria for
Class III.
Which premarket pathway should they pursue?
A) 510(k)
B) PMA
C) De Novo
D) IDE
C) De Novo
Explanation:
The De Novo pathway is designed for low to
moderate-risk devices that do not have a predicate
but do not pose high risk. Since the h ydration
monitoring device is novel but presents mini mal
safety concerns, the company should submit a De
Novo request. If granted, this device would be
classified as Class I or II and could serve as a
predicate for future 510(k) submissions.
