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RAC devices practice exam Questions and CORRECT Answers 2024/2025
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RAC devices practice exam Questions and CORRECT Answers 2024/2025
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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 - ANSA 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? - ANSContact 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 - ANSCarcinogenicity
If a device fails to comply with any paragraph of the QSR is it adulterated? - ANSYes
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 - ANSThe 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? -
ANSSend 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) - ANSBLA 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) - ANSD. A traditional or abbreviated 510(k)
What source should the regulatory professional consult to determine when a product's patent
and exclusivity will expire? - ANSThe 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?
- ANSNegotiate 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 - ANSStock recovery
When a manufacturer is performing design validation activities, which element is NOT included
as a requirement under QSR's device design validation section? - ANSTranslation 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 - ANSA The labeling is revised
How is labeling reconciliation during manufacturing BEST accomplished? - ANSAccounting 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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