RAC EXAM QUIZ (RAPID FIRE STYLE)
Terms in this set (70)
What is the most appropriate C
regulatory pathway in the
U.S.?
A. No submission is required if
the change is documented
internally
B. Submit a Special 510(k)
because the change is
limited to software
C. Submit a Traditional 510(k)
because the new algorithm
significantly affects
performance
D. Submit a PMA supplement
because the device now
provides clinical
information
A manufacturer wants to B
change sterilization method
from EtO to gamma for a Class
III PMA device...
What type of PMA supplement is
required?
A. Real-Time PMA Supplement
B. 180-Day PMA Supplement
C. Special PMA Supplement
D. Manufacturing Site Change
Supplement
,A Class C IVD (Companion B
Diagnostic) is being
introduced in the EU...
What must be included in the
technical documentation?
A. Declaration of
Conformity prior to
notified body review
B. Performance Evaluation
Plan and Report,
including scientific
validity
C. Only a self-certification of
QMS if ISO 13485 certified
D. Summary of Safety and
Performance in English only
Which statement about SSP B
requirements is correct?
A. SSP is required for all Class
IIb medical devices and all
Class B IVDs
B. SSP must be submitted for
all Class III and implantable
medical devices and for all
Class C and D IVDs
C. SSP is only required when a
device is first placed on the
market or if serious adverse
events are reported
D. SSP is optional if the device is
CE marked under a legacy
certificate and has not been
modified
Multiplex PCR near-patient C
diagnostic for SARS-CoV-2,
influenza A/B, and RSV...
How is it classified under EU
IVDR?
A. Class A
B. Class B
C. Class C
D. Class D
Orthopedic screw lot B
manufactured undersized, no
injuries but could cause
instability...
FDA recall classification?
A. Class I
, B. Class II
C. Class III
D. Market Withdrawal
Class II reusable surgical B
instrument in U.S.
- UDI requirement?
A. The UDI must be placed
only on the device
packaging
B. The UDI must be
directly marked on the
device itself
C. No UDI is required since it is
a reusable device
D. Only the production
identifier needs to be
included
Terms in this set (70)
What is the most appropriate C
regulatory pathway in the
U.S.?
A. No submission is required if
the change is documented
internally
B. Submit a Special 510(k)
because the change is
limited to software
C. Submit a Traditional 510(k)
because the new algorithm
significantly affects
performance
D. Submit a PMA supplement
because the device now
provides clinical
information
A manufacturer wants to B
change sterilization method
from EtO to gamma for a Class
III PMA device...
What type of PMA supplement is
required?
A. Real-Time PMA Supplement
B. 180-Day PMA Supplement
C. Special PMA Supplement
D. Manufacturing Site Change
Supplement
,A Class C IVD (Companion B
Diagnostic) is being
introduced in the EU...
What must be included in the
technical documentation?
A. Declaration of
Conformity prior to
notified body review
B. Performance Evaluation
Plan and Report,
including scientific
validity
C. Only a self-certification of
QMS if ISO 13485 certified
D. Summary of Safety and
Performance in English only
Which statement about SSP B
requirements is correct?
A. SSP is required for all Class
IIb medical devices and all
Class B IVDs
B. SSP must be submitted for
all Class III and implantable
medical devices and for all
Class C and D IVDs
C. SSP is only required when a
device is first placed on the
market or if serious adverse
events are reported
D. SSP is optional if the device is
CE marked under a legacy
certificate and has not been
modified
Multiplex PCR near-patient C
diagnostic for SARS-CoV-2,
influenza A/B, and RSV...
How is it classified under EU
IVDR?
A. Class A
B. Class B
C. Class C
D. Class D
Orthopedic screw lot B
manufactured undersized, no
injuries but could cause
instability...
FDA recall classification?
A. Class I
, B. Class II
C. Class III
D. Market Withdrawal
Class II reusable surgical B
instrument in U.S.
- UDI requirement?
A. The UDI must be placed
only on the device
packaging
B. The UDI must be
directly marked on the
device itself
C. No UDI is required since it is
a reusable device
D. Only the production
identifier needs to be
included
