Question
Answer
Explanation
A company wants to export a device that has not
received FDA approval but is legal in Europe. What
document is needed?
A) Certificate to Foreign Government
B) Certificate of Exportability
C) 510(k) Clearance
D) PMA Approval
B) Certificate of Exportability
Explanation: Devices not FDA-approved but meeting
foreign standards require a Certificate of Exportability
(Section 801(e)(1) of the FD&C Act).
When can an IRB waive informed consent for a clinical
trial?
A) If the trial presents minimal risk and meets ethical
criteria
B) Never, it is always required
C) Only if the FDA allows it
D) When requested by the sponsor
A) If the trial presents minimal risk and meets ethical criteria
Explanation: Under 21 CFR 56.109, IRBs can waive
consent if the study poses minimal risk and obtaining
consent is impractical.
Under the FDA's Good Clinical Practice (GCP) guidelines,
what must be documented in clinical trials?
A) Only the statistical analysis plan
B) Only the recruitment strategies used
C) All aspects of the trial, including data, participant
consent, and adverse events
D) Only the results of the clinical trial
C) All aspects of the trial, including data, participant consent,
and adverse events
When multiple facilities are involved in a Class III device's
design, assembly or processing, the PMA holder should
do all of the following EXCEPT:
A. Ensure the quality systems in all facilities are in
compliance with 21 CFR 820 regulations, as applicable
B. Include in the PMA submission a complete description
of the device's manufacturing, processing, packing,
storage and installation methods
C. Provide written authorization to reference the Device
Master File information from a contracted facility
D. Submit quality system information only for the facility
involved in the design of the device
D. Submit quality system information only for the facility
involved in the design of the device
