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RAC devices practice exam Questions and Answers (Latest Update 2025)
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RAC devices practice exam Questions and Answers (Latest Update 2025)
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RAC devices practice exam Questionsand Answers (Latest Update 2025)
A 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 - Correct Answer ✅ 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? - Correct Answer ✅
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:
, RAC devices practice exam Questions
and Answers (Latest Update 2025)
0 Intracutaneous irritation,
1 Genotoxicity,
2 Acute toxicity,
3 Carcinogenicity - Correct Answer ✅ Carcinogenicity
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
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