RAC Device Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. For sterile devices, what type of test is required before market release:
[A]Verification test
[B]Validation test
[C]Quality test
[D]Sterility test - ANSWER [D]Sterility test
2. How many days of an FDA request, before distribution of a tracked device to a
patient, the distributor name and contact information of the distributors and the
location of the device:
[A]3 working days
[B]3 calendar days
[C]5 working days
[D]10 working days - ANSWER [A]3 working days
,3. How many days of an FDA request, after distribution or implantatio, the UDI or
other identifier, date shipped and date to patient, patient and physician
information:
[A]3 working days
[B]3 calendar days
[C]10 working days
[D]10 calendar days - ANSWER [C]10 working days
4. Reserve sample consists of at least _____ the quantity necessary for all tests
required.
[A]double
[B]triple
[C]half
[D]quarter - ANSWER [A]double
5. All US medical regulations must be met by foreign establishments in order to
import products except:
[A]establishment registration
[B]device listing
[C]QSR manufacturing
[D]GMP manufacturing
[E]MDR
[F]510k or PMA - ANSWER [D]GMP manufacturing
,6. Devices approved to be marketed in US may be exported in the world with prior
FDA notification or approval:
[A]True
[B]False - ANSWER [B]False
can be exported without prior FDA notification or approval
7. All devices to be exported that are not cleared for marketing in US must adhere
to the following except:
[A]Meet the purchaser's specifications
[B]Not conflict with the importing country's laws
[C]Can be sold in domestic commerce
[D]May require certificate of Exportability or certificate of foreign government -
ANSWER [C]Can be sold in domestic commerce
8. What device class require FDA approval to export:
[A]Class I
[B]Class II cleared
[C]Class III without PMA
[D]Class III with PMA - ANSWER [C]Class III without PMA
9. What is the prerequisite to a Warning Letter?
[A]481
[B]482
, [C]483
[D]484 - ANSWER [C]483
10. What is the recall class when the use of or exposure to a suspected drug may
cause temporary or medically reversible adverse health consequences or where
the probability of serious adverse health consequence is remote.
[A]Class I
[B]Class II
[C]Class III
[D]Class IV - ANSWER [B]Class II
11. What is the recall class when the use of or exposure to a suspected product is
not likely to cause adverse health consequences, but the product violates FDA
labeling or manufacturing laws.
[A]Class I
[B]Class II
[C]Class III
[D]Class IV - ANSWER [C]Class III
12. Recall strategy elements must include except:
[A]Depth of Recall
[B]Public Warning
[C]Effectiveness Checks
[D]Public compensation - ANSWER [D]Public compensation
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. For sterile devices, what type of test is required before market release:
[A]Verification test
[B]Validation test
[C]Quality test
[D]Sterility test - ANSWER [D]Sterility test
2. How many days of an FDA request, before distribution of a tracked device to a
patient, the distributor name and contact information of the distributors and the
location of the device:
[A]3 working days
[B]3 calendar days
[C]5 working days
[D]10 working days - ANSWER [A]3 working days
,3. How many days of an FDA request, after distribution or implantatio, the UDI or
other identifier, date shipped and date to patient, patient and physician
information:
[A]3 working days
[B]3 calendar days
[C]10 working days
[D]10 calendar days - ANSWER [C]10 working days
4. Reserve sample consists of at least _____ the quantity necessary for all tests
required.
[A]double
[B]triple
[C]half
[D]quarter - ANSWER [A]double
5. All US medical regulations must be met by foreign establishments in order to
import products except:
[A]establishment registration
[B]device listing
[C]QSR manufacturing
[D]GMP manufacturing
[E]MDR
[F]510k or PMA - ANSWER [D]GMP manufacturing
,6. Devices approved to be marketed in US may be exported in the world with prior
FDA notification or approval:
[A]True
[B]False - ANSWER [B]False
can be exported without prior FDA notification or approval
7. All devices to be exported that are not cleared for marketing in US must adhere
to the following except:
[A]Meet the purchaser's specifications
[B]Not conflict with the importing country's laws
[C]Can be sold in domestic commerce
[D]May require certificate of Exportability or certificate of foreign government -
ANSWER [C]Can be sold in domestic commerce
8. What device class require FDA approval to export:
[A]Class I
[B]Class II cleared
[C]Class III without PMA
[D]Class III with PMA - ANSWER [C]Class III without PMA
9. What is the prerequisite to a Warning Letter?
[A]481
[B]482
, [C]483
[D]484 - ANSWER [C]483
10. What is the recall class when the use of or exposure to a suspected drug may
cause temporary or medically reversible adverse health consequences or where
the probability of serious adverse health consequence is remote.
[A]Class I
[B]Class II
[C]Class III
[D]Class IV - ANSWER [B]Class II
11. What is the recall class when the use of or exposure to a suspected product is
not likely to cause adverse health consequences, but the product violates FDA
labeling or manufacturing laws.
[A]Class I
[B]Class II
[C]Class III
[D]Class IV - ANSWER [C]Class III
12. Recall strategy elements must include except:
[A]Depth of Recall
[B]Public Warning
[C]Effectiveness Checks
[D]Public compensation - ANSWER [D]Public compensation
