RAC Device Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. 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 - ANSWER Carcinogenicity
2. If a device fails to comply with any paragraph of the QSR is it adulterated? -
ANSWER Yes
3. What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire?
0 Federal Register
1 TheOrange Book,
2 Patient and Trademark Office,
,3 Copyright Office - ANSWER The orange book
4. What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire? - ANSWER The Orange Book
5. 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? - ANSWER Negotiate with
the review division.
6. 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 - ANSWER Stock recovery
6. When a manufacturer is performing design validation activities, which
element is NOT included as a requirement under QSR's device design
validation section? - ANSWER Translation of device design into production
specifications.
,7. 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 - ANSWER A The labeling is revised
8. How is labeling reconciliation during manufacturing BEST accomplished? -
ANSWER Accounting for product labeling pre- and post-processing
9. 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
B. Equipment change: alternate equipment same design
C. Process change: adjustment of equipment beyond
D. Site change: same contiguous campus - ANSWER A. Component change:
deletion of color/flavor
10. Record-keeping requirements for marketed products are intended to provide
assurance of which of the following?
A. Continued labeling claims,
B. Field performance,
C. Maintenance of product safety
D Traceability in distribution - ANSWER D Traceability in distribution
, 11. The Declaration of Conformity supporting the CE marking of a Class I medical
device includes all of the following EXCEPT:
A. The signature of the Notified Body
B Identification of the directives
C. The manufacturer's name and address,
D Product Information (name, type or model number - ANSWER A. The
signature of the Notified Body
12. A manufacturer of an implanted medical device containing non-viable bovine
material of animal origin MUST: - ANSWER Request a certificate for the bovine
material.
13. A clinical trial of a medical device can begin how many days after notification
is sent to the Competent Authority?
A 30 days,
B 45days,
C 60days,
D As soon as Ethical Committee approval is received - ANSWER C 60days
14. A medical device contains electrical parts that could create EMC interference.
The manufacturer intends to CE mark the medical device under MDD 93/42/EEC.
Which of the following is CORRECT?
A. CEmarking the medical device under MDD 93/42/EEC is insufficient.
B. CEmarking the medical device under MDD 93/42/EEC is sufficient.
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. 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 - ANSWER Carcinogenicity
2. If a device fails to comply with any paragraph of the QSR is it adulterated? -
ANSWER Yes
3. What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire?
0 Federal Register
1 TheOrange Book,
2 Patient and Trademark Office,
,3 Copyright Office - ANSWER The orange book
4. What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire? - ANSWER The Orange Book
5. 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? - ANSWER Negotiate with
the review division.
6. 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 - ANSWER Stock recovery
6. When a manufacturer is performing design validation activities, which
element is NOT included as a requirement under QSR's device design
validation section? - ANSWER Translation of device design into production
specifications.
,7. 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 - ANSWER A The labeling is revised
8. How is labeling reconciliation during manufacturing BEST accomplished? -
ANSWER Accounting for product labeling pre- and post-processing
9. 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
B. Equipment change: alternate equipment same design
C. Process change: adjustment of equipment beyond
D. Site change: same contiguous campus - ANSWER A. Component change:
deletion of color/flavor
10. Record-keeping requirements for marketed products are intended to provide
assurance of which of the following?
A. Continued labeling claims,
B. Field performance,
C. Maintenance of product safety
D Traceability in distribution - ANSWER D Traceability in distribution
, 11. The Declaration of Conformity supporting the CE marking of a Class I medical
device includes all of the following EXCEPT:
A. The signature of the Notified Body
B Identification of the directives
C. The manufacturer's name and address,
D Product Information (name, type or model number - ANSWER A. The
signature of the Notified Body
12. A manufacturer of an implanted medical device containing non-viable bovine
material of animal origin MUST: - ANSWER Request a certificate for the bovine
material.
13. A clinical trial of a medical device can begin how many days after notification
is sent to the Competent Authority?
A 30 days,
B 45days,
C 60days,
D As soon as Ethical Committee approval is received - ANSWER C 60days
14. A medical device contains electrical parts that could create EMC interference.
The manufacturer intends to CE mark the medical device under MDD 93/42/EEC.
Which of the following is CORRECT?
A. CEmarking the medical device under MDD 93/42/EEC is insufficient.
B. CEmarking the medical device under MDD 93/42/EEC is sufficient.
