RAC devices practice exam
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
If a device fails to comply with any paragraph of the QSR is it adulterated? - CORRECT ANSWER-
Yes
What source should the regulatory professional consult to determine when a product's patent
and exclusivity will expire?
0 FederalRegister
1 TheOrange Book,
2 Patentand Trademark Office,
3 CopyrightOffice - CORRECT ANSWER-The orange book
An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a
submitted 510(k) application. Some of the information is not readily available and may require
additional data collection. What is the BEST course of action for the regulatory professional? -
CORRECT ANSWER-Send a letter with anticipated response time.
An IVD submission could be submitted as a(n):
A. NDA
, B. BLA
C. 510(k)
D. BLA or 510(k) - CORRECT ANSWER-BLA or 510(k)
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 most appropriate?
A. A PMA
B. An Investigational Device Exemption
C. A Special 510(k)
D. A traditional or abbreviated 510(k) - CORRECT ANSWER-D. A traditional or abbreviated 510(k)
What source should the regulatory professional consult to determine when a product's patent
and exclusivity will expire? - CORRECT ANSWER-The Orange Book
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim in the labeling, while the FDA is
proposing a more restrictive claim. What is the regulatory professional's BEST course of action?
- CORRECT ANSWER-Negotiate with the review division.
A medical device that has just received marketing approval outside the US is to be shipped from
the US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor,
who confirms the product has not yet been shipped and is still at its warehouse in the US.
Company XYZ requests the foreign distributor return the medical device immediately. The
enforcement activity described is an example of a:
A. Market Withdrawal
B. Stock recovery
C. Class I recall,
D. Class III recall - CORRECT ANSWER-Stock recovery
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
If a device fails to comply with any paragraph of the QSR is it adulterated? - CORRECT ANSWER-
Yes
What source should the regulatory professional consult to determine when a product's patent
and exclusivity will expire?
0 FederalRegister
1 TheOrange Book,
2 Patentand Trademark Office,
3 CopyrightOffice - CORRECT ANSWER-The orange book
An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a
submitted 510(k) application. Some of the information is not readily available and may require
additional data collection. What is the BEST course of action for the regulatory professional? -
CORRECT ANSWER-Send a letter with anticipated response time.
An IVD submission could be submitted as a(n):
A. NDA
, B. BLA
C. 510(k)
D. BLA or 510(k) - CORRECT ANSWER-BLA or 510(k)
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 most appropriate?
A. A PMA
B. An Investigational Device Exemption
C. A Special 510(k)
D. A traditional or abbreviated 510(k) - CORRECT ANSWER-D. A traditional or abbreviated 510(k)
What source should the regulatory professional consult to determine when a product's patent
and exclusivity will expire? - CORRECT ANSWER-The Orange Book
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim in the labeling, while the FDA is
proposing a more restrictive claim. What is the regulatory professional's BEST course of action?
- CORRECT ANSWER-Negotiate with the review division.
A medical device that has just received marketing approval outside the US is to be shipped from
the US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor,
who confirms the product has not yet been shipped and is still at its warehouse in the US.
Company XYZ requests the foreign distributor return the medical device immediately. The
enforcement activity described is an example of a:
A. Market Withdrawal
B. Stock recovery
C. Class I recall,
D. Class III recall - CORRECT ANSWER-Stock recovery
