Question
Answer
Explanation
Company F is preparing a 510(k) submission for a device
that will be sold as part of a system with other devices.
Which of the following is TRUE regarding their
submission?
a) They must submit separate 510(k)s for each component
of the system
b) They can only submit a single 510(k) if all components
are novel devices
c) They may submit a single 510(k) for the entire system
if it's intended to be used as such
d) System submissions are not allowed under the 51 0(k)
process
c) They may submit a single 510(k) for the entire
system if it's intended to be used as such
A manufacturer receives a Warning Letter from the
FDA following an inspection. Which of the following
is the MOST appropriate initial response?
a) Submit a corrective action plan within 15 business
days
b) Immediately stop distribution of all products until
the issue is resolved
c) Conduct an internal audit and report back to FDA
within 60 days
d) Request an informal dispute resolution meeting
before responding
a) Submit a corrective action plan within 15
business days
A medical device manufacturer is planning to modify
an FDA-cleared Class II device by changing the
material of a key component. What is the MOST
appropriate regulatory path for this change?
a) Submit a new 510(k) if the change affects safety
or effectiveness
b) File a Special 510(k) since it is a minor
modification
c) Submit a De Novo request because the material
change makes it a novel device
d) Make the change under a Letter-to-File with
internal documentation
a) Submit a new 510(k) if the change affects
safety or effectiveness
RAC Book page 147.
Explanation:
Material changes may impact biocompatibility,
safety, or effectiveness, requiring a new 510(k). A
Special 510(k) is only appropriate when
modifications do not require additional testing to
demonstrate safety or effectiveness.
