RAPS Practice Test (New 2026/ 2027
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim on the labeling, while FDA
is proposing a more restrictive claim. What is the regulatory professional's BEST
course of action?
A. Accept the FDA's proposed labeling
B. Contact the center's director
C. Contact the ombudsman
D. Negotiate with the review division - Correct answer D. Negotiate with the review
division
Which class of devices has no regulatory quality system req?
A. Class I
B. Class II
C. Class III
D. Class IV - Correct answer A. Class I
,A new Class III medical device technology is developed by a company, and the
company wishes to market the product in the shortest possible time. What first course
of action should the regulatory professional recommend?
A. Define the purpose of the product so it is a Class IIb
B. Work with a physician to complete the Special Access
C. Test it in a non-EU country under the Helsinki
D. Collect required clinical data - Correct answer D. Collect required clinical data
Which of the following is required for all medical devices?
A. EC type examination certificate
B. Multilanguage labeling
C. NB involvement
D. Technical documentation - Correct answer D. Technical documentation
What does a regulatory professional need to address when preparing an internal audit
plan?
,A. The audit scope, importance of process, findings from previous audits, and selection
of auditors
B. The audit scope, findings from previous audits, selection of auditors, and follow up
activities taken with verifications
C. The findings from previous audits, selection of auditors, and follow up activities
taken with verifications
D. The importance of the process, findings from previous audits, and follow up
activities taken with verifications - Correct answer A. The audit scope, importance of
process, findings from previous audits, and selection of auditors
What information is included in the Official Journal of the European Union?
A. Draft guidelines relevant to pharmaceuticals
B. Notices of product recalls in EU
C. Proposed and final EU legislation
D. Summaries of final EU legislation in every EU language - Correct answer C.
Proposed and final EU legislation
To whom is the MDD 93/42/EEC addressed?
, A. CA
B. Manufacturers
C. EU Member States
D. NB - Correct answer C. EU Member States
When can a clinical investigation begin for a Class I device with Ethics Committee
approval?
A. Immediately in a new investigational site
B. Immediately after date of notification
C. Sixty days after date of notification
D. Following compliance with Annex IX of the MDD - Correct answer B. Immediately
after the date of notification
A device contains electrical parts that could create EMC interference. The mfger
intends to CE mark the device under MDD 93/42/EEC. Which of the following is
CORRECT?
A. CE marking under MDD 93/42/EEC is sufficient
B. CE marking under 93/EEC is incomplete
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim on the labeling, while FDA
is proposing a more restrictive claim. What is the regulatory professional's BEST
course of action?
A. Accept the FDA's proposed labeling
B. Contact the center's director
C. Contact the ombudsman
D. Negotiate with the review division - Correct answer D. Negotiate with the review
division
Which class of devices has no regulatory quality system req?
A. Class I
B. Class II
C. Class III
D. Class IV - Correct answer A. Class I
,A new Class III medical device technology is developed by a company, and the
company wishes to market the product in the shortest possible time. What first course
of action should the regulatory professional recommend?
A. Define the purpose of the product so it is a Class IIb
B. Work with a physician to complete the Special Access
C. Test it in a non-EU country under the Helsinki
D. Collect required clinical data - Correct answer D. Collect required clinical data
Which of the following is required for all medical devices?
A. EC type examination certificate
B. Multilanguage labeling
C. NB involvement
D. Technical documentation - Correct answer D. Technical documentation
What does a regulatory professional need to address when preparing an internal audit
plan?
,A. The audit scope, importance of process, findings from previous audits, and selection
of auditors
B. The audit scope, findings from previous audits, selection of auditors, and follow up
activities taken with verifications
C. The findings from previous audits, selection of auditors, and follow up activities
taken with verifications
D. The importance of the process, findings from previous audits, and follow up
activities taken with verifications - Correct answer A. The audit scope, importance of
process, findings from previous audits, and selection of auditors
What information is included in the Official Journal of the European Union?
A. Draft guidelines relevant to pharmaceuticals
B. Notices of product recalls in EU
C. Proposed and final EU legislation
D. Summaries of final EU legislation in every EU language - Correct answer C.
Proposed and final EU legislation
To whom is the MDD 93/42/EEC addressed?
, A. CA
B. Manufacturers
C. EU Member States
D. NB - Correct answer C. EU Member States
When can a clinical investigation begin for a Class I device with Ethics Committee
approval?
A. Immediately in a new investigational site
B. Immediately after date of notification
C. Sixty days after date of notification
D. Following compliance with Annex IX of the MDD - Correct answer B. Immediately
after the date of notification
A device contains electrical parts that could create EMC interference. The mfger
intends to CE mark the device under MDD 93/42/EEC. Which of the following is
CORRECT?
A. CE marking under MDD 93/42/EEC is sufficient
B. CE marking under 93/EEC is incomplete
