DEVICE RAC CERTIFICATION SCRIPT 2026
QUESTIONS WITH SOLUTIONS GRADED 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 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.
◍ 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 XY
Z. Company XYZ contacts the foreign distributor, who confirms the product
has not yet been shipped and is still at its warehouse in the U
S. 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
◍ A US-based manufacturer produces a Class I medical device with a CE
Mark that is sold in Germany. The authorized representative is located in the
Netherlands. An identical medical device is sold outside of the E
U. An incident is reported in Japan and leads to an FSC
A. The US-based manufacturer immediately identifies the problem and
makes a change to a mold to prevent future incidents. Whom should the
US-based manufacturer inform of the situation?A Appropriate authorities
outside the EU, B CA in Germany, C CA in the NetherlandsD NB.
Answer: C. CA in the Netharlands(CA of AR)
,◍ Good Engineering Practice (GEP).
Answer: Proven and accepted engineering methods, procedures, and
practices that provide appropriate, cost-effective, and well-documented
solutions to meet user requirements and compliance with applicable
regulations.
◍ Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act).
Answer: Requires drugs to be proven safe before being placed on the
market. It also permitted marketing to begin 60 days after submission of a
new drug application if FDA posed no objection.
◍ Device History Record (DHR).
Answer: Production record for medical devices that include acceptance
records for individual units or batches of product, along with product counts,
labels and any unique product identifiers that have been applied.
◍ To whom is the MDD 93/42/EEC addressed?A CA,B Manufacturers, C
EUmember states, D NB.
Answer: D. EU member states
◍ 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 revisedB The product is
recalledC The product is redesigned, D A"Dear Doctor" letter is issued.
Answer: A The labeling is revised
◍ 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?.
Answer: Contact the review division to determine whether a 510(k) or PMA
should be prepared.
◍ To maintain a valid CE Mark certificate for devices under Annex II, the
manufacturer should:.
Answer: Collect all relevant new information, compile it and update
technical files for audit and review by the Notified Body as required during
, the five-year period following CE marking
◍ A medical device contains electrical parts that could create EMC
interference. The manufacturer intends to CE mark the medical device under
MDD 93/42/EE
C. 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.
C. The manufacturer needs to conform to MDD 89/336/EEC,
D. The manufacturer needs to conform to EN ISO 60601.
Answer: B. CE marking the medical device under MDD 93/42/EEC is
sufficient.
◍ Your Notified Body is classifying your device differently from you
assessment. After reviewing the classification rules, you are certain your
classification is correct; however, the Notified Body is not willing to
reconsider. What is the BEST strategy to resolve this situation?.
Answer: Ask the Notified Body to get an opinion from its Competent
Authority
◍ What is the BEST source for determining the format of an MAA intended
for submission to an HA?A GMP, B Local HA guidelines, C ICH, D WHO.
Answer: B. Local HA guidelinesMAA = Marketing Authorization
ApplicationHA = Health Authority
◍ A manufacturer sells 1,500 medical devices in the two months following
launch. A user, but not a patient, is seriously injured while using the medical
device. The investigation reveals the cause to be an error in a software
subroutine that has a one in 195,000 chance of happening. Management is
concerned about how the incident may result in serious problems in the
marketplace. What recommendation is MOST appropriate for the regulatory
professional to make to management?.
Answer: Discuss the incident with the authorities and send an advisory letter
to each customer.
◍ The internal audit area of a company is itself due for an internal review and
, audit. The internal audit procedure was written by an external
regulatory/quality consultant. The quality manager is responsible for setting
the internal audit schedule, ensuring audit documentation is complete and
that actions are taken. The BEST person to conduct this audit is the:A
Document control manager,B Regulatory quality consultant ,C Quality
manager, D Quality inspector who reports to the quality manager.
Answer: A. Document control manager.Want someone who is not associated
with the audit procedure
◍ 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 safetyD Traceability in distribution.
Answer: D Traceability in distribution
◍ The European Medical Device Nomenclature (EMDN).
Answer: will be used by manufacturers when registering their medical
devices in the EUDAMED database
◍ 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?.
Answer: Collect required clinical data
◍ 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
◍ How is labeling reconciliation during manufacturing BEST accomplished?.
Answer: Accounting for product labeling pre- and post-processing
QUESTIONS WITH SOLUTIONS GRADED 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 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.
◍ 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 XY
Z. Company XYZ contacts the foreign distributor, who confirms the product
has not yet been shipped and is still at its warehouse in the U
S. 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
◍ A US-based manufacturer produces a Class I medical device with a CE
Mark that is sold in Germany. The authorized representative is located in the
Netherlands. An identical medical device is sold outside of the E
U. An incident is reported in Japan and leads to an FSC
A. The US-based manufacturer immediately identifies the problem and
makes a change to a mold to prevent future incidents. Whom should the
US-based manufacturer inform of the situation?A Appropriate authorities
outside the EU, B CA in Germany, C CA in the NetherlandsD NB.
Answer: C. CA in the Netharlands(CA of AR)
,◍ Good Engineering Practice (GEP).
Answer: Proven and accepted engineering methods, procedures, and
practices that provide appropriate, cost-effective, and well-documented
solutions to meet user requirements and compliance with applicable
regulations.
◍ Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act).
Answer: Requires drugs to be proven safe before being placed on the
market. It also permitted marketing to begin 60 days after submission of a
new drug application if FDA posed no objection.
◍ Device History Record (DHR).
Answer: Production record for medical devices that include acceptance
records for individual units or batches of product, along with product counts,
labels and any unique product identifiers that have been applied.
◍ To whom is the MDD 93/42/EEC addressed?A CA,B Manufacturers, C
EUmember states, D NB.
Answer: D. EU member states
◍ 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 revisedB The product is
recalledC The product is redesigned, D A"Dear Doctor" letter is issued.
Answer: A The labeling is revised
◍ 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?.
Answer: Contact the review division to determine whether a 510(k) or PMA
should be prepared.
◍ To maintain a valid CE Mark certificate for devices under Annex II, the
manufacturer should:.
Answer: Collect all relevant new information, compile it and update
technical files for audit and review by the Notified Body as required during
, the five-year period following CE marking
◍ A medical device contains electrical parts that could create EMC
interference. The manufacturer intends to CE mark the medical device under
MDD 93/42/EE
C. 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.
C. The manufacturer needs to conform to MDD 89/336/EEC,
D. The manufacturer needs to conform to EN ISO 60601.
Answer: B. CE marking the medical device under MDD 93/42/EEC is
sufficient.
◍ Your Notified Body is classifying your device differently from you
assessment. After reviewing the classification rules, you are certain your
classification is correct; however, the Notified Body is not willing to
reconsider. What is the BEST strategy to resolve this situation?.
Answer: Ask the Notified Body to get an opinion from its Competent
Authority
◍ What is the BEST source for determining the format of an MAA intended
for submission to an HA?A GMP, B Local HA guidelines, C ICH, D WHO.
Answer: B. Local HA guidelinesMAA = Marketing Authorization
ApplicationHA = Health Authority
◍ A manufacturer sells 1,500 medical devices in the two months following
launch. A user, but not a patient, is seriously injured while using the medical
device. The investigation reveals the cause to be an error in a software
subroutine that has a one in 195,000 chance of happening. Management is
concerned about how the incident may result in serious problems in the
marketplace. What recommendation is MOST appropriate for the regulatory
professional to make to management?.
Answer: Discuss the incident with the authorities and send an advisory letter
to each customer.
◍ The internal audit area of a company is itself due for an internal review and
, audit. The internal audit procedure was written by an external
regulatory/quality consultant. The quality manager is responsible for setting
the internal audit schedule, ensuring audit documentation is complete and
that actions are taken. The BEST person to conduct this audit is the:A
Document control manager,B Regulatory quality consultant ,C Quality
manager, D Quality inspector who reports to the quality manager.
Answer: A. Document control manager.Want someone who is not associated
with the audit procedure
◍ 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 safetyD Traceability in distribution.
Answer: D Traceability in distribution
◍ The European Medical Device Nomenclature (EMDN).
Answer: will be used by manufacturers when registering their medical
devices in the EUDAMED database
◍ 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?.
Answer: Collect required clinical data
◍ 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
◍ How is labeling reconciliation during manufacturing BEST accomplished?.
Answer: Accounting for product labeling pre- and post-processing
