Question
Answer
Explanation
A medical device company plans to modify
an FDA-cleared infusion pump to include
wireless connectivity for remote
monitoring. The intended use remains t he
same, but the modification allows
healthcare providers to adjust infusion
settings remotely.
What is the most appropriate regulatory
action?
A) No new 510(k) is required, as the
intended use remains unchanged
B) Submit a Special 510(k) because the
modification is a minor design change
C) Submit a new Traditional 510(k)
because the wireless feature introduces new
risks
D) Submit a PMA because the change
significantly alters the device
C) Submit a new Traditional 510(k)
because the wireless feature introduces new
risks
A manufacturer of an FDA-cleared Class II
laparoscopic surgical tool wants to make a
cosmetic change by switching from blue to
black casing for better visibility in low-light
surgical environments. The device's
materials, design, and intended use remain
unchanged.
What is the most appropriate regulatory
action?
A) Submit a new Traditional 510(k)
B) Submit a Special 510(k)
C) Submit a PMA supplement
D) No new 510(k) is required
D) No new 510(k) is required
The correct answer is D. A 510(k) is not required
for purely cosmetic changes that do not affect the
safety or effectiveness of the device. Since the
materials, design, and intended use remain
unchanged, the manufacturer can document t he
change internally as part of design controls and
change management records under 21 CFR
820.30(i) (Design Changes).
