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RAC DEVICES PRACTICE EXAM
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RAC DEVICES PRACTICE EXAM
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RAC DEVICES PRACTICE EXAMA medical device manufacturer is preparing a submission that requires a Declaration of
Conformity with design control requirements. What type of submission is the
manufacturer preparing to submit to FDA?
0 A PMA
1 A Special 510(k),
2 An Individual Device Exemption (IDE),
3 An Annual Report for a PMA - Answers- A Special 510(k)
A company wishes to expand existing labeling for a medical device to include a new
indication for use. What action should the regulatory professional take FIRST? -
Answers- Contact the review division to determine whether a 510(k) or PMA should be
prepared.
A company is submitting a PMA for a permanent implant. The company has performed
biocompatibility testing based on ISO requirements and believes the package is
complete. Which of the following testing does the company absolutely need to
demonstrate long-term safety of its device:
0 Intracutaneous irritation,
1 Genotoxicity,
2 Acute toxicity,
3 Carcinogenicity - Answers- Carcinogenicity
If a device fails to comply with any paragraph of the QSR is it adulterated? - Answers-
Yes
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k) - Answers- 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) - Answers- 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? - Answers- 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? - Answers- 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 - Answers- Stock recovery
When a manufacturer is performing design validation activities, which element is NOT
included as a requirement under QSR's device design validation section? - Answers-
Translation of device design into production specifications.
If a device failure is occurring with greater than expected frequency and investigation of
the problem implicates improper use by the end user, which of the following should
occur?
A The labeling is revised
B The product is recalled
C The product is redesigned,
D A"Dear Doctor" letter is issued - Answers- A The labeling is revised
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 - Answers- 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? - Answers- Send a letter with anticipated response
time.
How is labeling reconciliation during manufacturing BEST accomplished? - Answers-
Accounting for product labeling pre- and post-processing
Which of the following changes can be submitted without an updated batch record for a
modified-release product?
A. Component change: deletion of color/flavor
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