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RAC-US - Regulatory Affairs Exam


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Sample Questions

Question No 1:
While seeking a new Class III indication for a medical device that is currently on the market as
Class II, a company received a vote of "non-approvable" from an FDA Advisory Panel. Possible
course of action includes all of the following EXCEPT?
A.
B.
C.
D.

Continue marketing the device for its Class II indication


Update the current labeling to include the new indication
Proceed with a PMA submission to FDA
Request a face-to-face meeting post-panel meeting with FDA

Answer: B
Question No 2:
Company X is developing marketing materials for a Class II medical device known as "Y". In
one marketing piece, the company talks about the clinical data supporting the marketing of
the device. Which of the following statements is illegal and should NOT be included int eh
marketing materials?
A. Company X has conducted clinical studies to demonstrate safety and effectiveness of
device Y
B. Device Y is approved for marketing in the US
C. Warning: Device Y i not compatible with MRI equipment
D. Caution: Device Y, when improperly deployed, can cause bleeding

Answer: B
Question No 3:
The Quality System Regulation calls for the manufacturer of finished devices to carry out all
of the following EXCEPT?
A. Quality audits conducted by individuals who do not have direct responsibility for the
operation being audited.
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited

Answer: B

Question No 4:
The following are required per 21 CFR Part 820 Quality System Regulation (QSR) EXCEPT?
A.
B.
C.
D.

Device History Record (DHR)


Device Master Record (DMR)
Design History File (DHF)
Quality Manual (QM)

Answer: D
Question No 5:
What is the formal early collaboration meeting that was implemented throught the Food and
Drug Modernization Act (FDAMA)?
A.
B.
C.
D.

PDP Meeting
Agreement Meeting
Pre-IDE Meeting
Pre-PMA Meeting

Answer: B
Question No 6:
You are a German-based device manufacturer whose device is packaged in Ireland and sold in
the US through a US-based company. The 510(k) was written by a contract organization. The
label of our product may indicated any of the following EXCEPT"
A.
B.
C.
D.

The principle place of business in the US


The packaging location address
The address of the contractor who submitted the 510(k)
The address of the distributor

Answer: C
Question No 7:
A company intends to add an indication for use to a 510(k) device that is currently being
marketed but has not yet been distributed. Which type of submission is appropriate?
A.
B.
C.
D.

A PMA
An Investigation Device Exemption
A Special 510(k)
A traditional or abbreviated 510(k)

Answer: D
Question No 8:
A company begins to market its new device, a pacemaker (Class III) the same day that its
regulatory professional mails the Premaket Approval Application (PMA) to FDA. The
pacemaker is considered:
A.
B.
C.
D.

Legally marketed
Misbranded
Investigational
Adulterated

Answer: D
Question No 9:
A medical device company allows its sales force to maintain a product inventory in the field.
The device has an expiration date indicated on its labeling. A sales person notes that one of
his products has expired and contacts the headquarters office for direction. He is told to
return the product to the headquarter office for replacement. The return of this product is
considered as what type of recall?
A.
B.
C.
D.

Not a recall-it is considered normal stock rotation


Class I recall
Class II recall
Class III recall

Answer: A
Question No 10:
When FDA declares a device from a 510(k) application to be Not Substantially Equivalent
(NSE) and requires a PMA. What is the most practicable first option for a company at this
stage?
A. File a PMA immediately
B. Petition CDRH to down-classify the device (de novo process)
C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and
effective as the predicate
D. Submit this product for approval in Europe

Answer: C

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