RAC DEVICES ACTUAL EXAM #4 QUESTIONS
WITH VERIFIED ANSWERS
A Special 510(k) must contain all of the following components EXCEPT
A. Proposed Labeling
B. Design Controls Activity Summary
C. 510(k) Summary or 510(k) Statement
D. Summary of Safety and Effectiveness Data
D. Summary of Safety and Effectiveness Data
A Special 510(k) does not require a Summary of Safety and Effectiveness Data. This
component is specific to PMA (Premarket Approval) applications. Special 510(k)s focus on
modifications to a legally marketed device and require the Proposed Labeling, Design Controls
Activity Summary, and either a 510(k) Summary or 510(k) Statement.
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test,
a microhematocrit analyzer that, among other intended uses, can determine the hematocrit
of a blood donor prior to donation of a blood product. The firm should address the 510(k)
submission to:
A. CDER
B. CBER
C. CDRH
D. OCP
B. CBER
In this case, the firm should submit the 510(k) to CBER (Center for Biologics Evaluation and
Research) because the microhematocrit analyzer is intended for use in determining the
hematocrit of blood donors, which relates to the safety of blood and blood products. CBER is
responsible for regulating biologics, including blood and blood products, so this falls under their
jurisdiction.
A company is planning to implement a few minor manufacturing changes for its FDA-
approved device. The company is currently conducting a clinical study for a new indication
using this device. The correct submission for the regulatory professional to make is the
A. PMA Amendment
B. IND Supplement
C. IDE 5-day Notice
D. CBE-30
C. IDE 5-day Notice
When a company is conducting a clinical study under an approved Investigational Device
Exemption (IDE) and plans to implement minor manufacturing changes to the device being
,studied, they must notify the FDA. For minor changes, the company typically submits an IDE 5-
day Notice before making the changes.
PMA Amendment: Used for changes to a device with an approved Premarket Approval (PMA),
not during an IDE.
IND Supplement: Applies to drugs or biologics under an Investigational New Drug (IND)
application, not devices.
A company begins to market its new device, a pacemaker (Class III) the same day its
regulatory professional submits the Premarket Approval Application (PMA) to FDA. The
pacemaker is considered:
A. Legally marketed
B. Misbranded
C. Investigational
D. Adulterated
D. Adulterated
Marketing a Class III device, such as a pacemaker, before receiving Premarket Approval (PMA)
from the FDA is illegal. As a result, the device is considered misbranded because it lacks the
required approval for marketing. Under FDA regulations, a device must have proper labeling and
necessary approvals before it can be legally marketed.
Legally marketed: Incorrect, as the device is marketed without FDA approval.
Investigational: Incorrect, because it is being marketed, not investigated under an IDE.
A company is developing a new device, and the device classification under which it would
fall is not clear. As the regulatory professional, you would make the following submission:
A. 510(k) Premarket Notification
B. Request for Designation
C. 513(g) Request for Information
D. Type A Meeting Request
C. 513(g) Request for Information
When the device classification is unclear, a regulatory professional would submit a 513(g)
Request for Information to the FDA. This request allows the company to seek information
from the FDA regarding the classification of the device and the regulatory requirements that
would apply.
510(k) Premarket Notification: Used when the classification and predicate device are known.
Request for Designation: Typically used for combination products to determine which FDA
center will lead the review.
Type A Meeting Request: This is specific to drugs or biologics and involves meetings with the
FDA for ongoing regulatory issues or guidance.
,The document required by the Quality System Regulation (QSR) that tracks each device's
manufacture by unit, lot and batch is the:
A. Device Master Record
B. Device History Record
C. Design History File
D. Device Master File
B. Device History Record
The Device History Record (DHR) is required by the Quality System Regulation (QSR) and
contains information that tracks the manufacturing history of each device by unit, lot, or batch. It
ensures that the device was manufactured according to the specifications in the Device Master
Record (DMR).
Device Master Record (DMR): Contains the specifications and instructions for manufacturing
the device but does not track individual production units.
Design History File (DHF): Documents the design and development of the device.
Device Master File (DMF): Not a regulatory requirement under QSR and is typically used for
drug master files, not device manufacturing tracking.
You are the regulatory expert in a small start-up medical device company. A clinical
investigation is required for your Class II medical device 510(k) submission. One of the
investigators who conducts the study also has received 1,000 stock options from your
company as part of his consulting agreement. What information related to this investigator
must be included with your 510k submission?
A. Form 3454, certifying lack of financial interests and arrangements
B. Form 3455, disclosing the stock options for the specific investigator
C. Form 3455, disclosing proprietary interest in the tested product
D. No additional forms are required
B. Form 3455, disclosing the stock options for the specific investigator
In this case, since the investigator has received stock options from your company, this constitutes
a financial interest that must be disclosed. Form 3455 is used to disclose such financial
arrangements, including stock options, which could potentially affect the outcome of the clinical
study.
Form 3454 is used when there are no financial interests to disclose, which does not apply here.
No additional forms are required would be incorrect because the stock options represent a
financial arrangement that needs to be reported.
Form 3455, disclosing proprietary interest in the tested product would be correct if the
investigator had proprietary interest in the device itself; however, in this case, the stock options
pertain to financial interest, so Form 3455 must still be used.
, The quality assurance manager of a small company with 12 employees is the company's
only internal auditor and has been performing all internal quality system audits for three
years. This does not meet the requirements for performing internal quality systems audits
because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality assurance manager in
quality auditing principles
C. Quality system audits cannot be performed by the same auditor for more than two
audits in a row
D. The Audit Reports need to be approved by a second internal auditor not involved with
the specific audit
A. Auditor independence has not been ensured
In quality management systems, including those under the Quality System Regulation (QSR) or
ISO 13485, auditor independence is a key requirement. An internal auditor must be
independent of the areas they are auditing to avoid conflicts of interest and ensure objective
assessments. Since the quality assurance manager is the only internal auditor and has been
conducting all audits for three years, their independence cannot be guaranteed, especially if they
are auditing areas they oversee.
The other options are not explicitly required by the regulations: There's no requirement that
someone else must train the auditor within the company. There's no limit on the number of
consecutive audits by the same auditor. Audit reports do not necessarily need to be approved by
a second internal auditor; the critical issue is the auditor's independence.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis
after treatment with an approved device. This side effect is not listed in the package insert.
This event must be reported by the manufacturer to FDA no later than:
A. 5 calendar days after receipt or becoming aware of information
B. 15 calendar days after receipt or becoming aware of information
C. 30 calendar days after receipt or becoming aware of information
D. The next quarterly report
C. 30 calendar days after receipt or becoming aware of information
Question Feedback
Serious injury must be reported within 30 days; see 21 CFR 803.50(a)
For medical devices, a serious injury must be reported within 30 days after receipt or becoming
aware of information, whether or not it is expected and stated in the IFU.
You work for a German-based device manufacturer that packages the device in Ireland
and sells the product in the US through a US-based company. The 510(k) was written by a
WITH VERIFIED ANSWERS
A Special 510(k) must contain all of the following components EXCEPT
A. Proposed Labeling
B. Design Controls Activity Summary
C. 510(k) Summary or 510(k) Statement
D. Summary of Safety and Effectiveness Data
D. Summary of Safety and Effectiveness Data
A Special 510(k) does not require a Summary of Safety and Effectiveness Data. This
component is specific to PMA (Premarket Approval) applications. Special 510(k)s focus on
modifications to a legally marketed device and require the Proposed Labeling, Design Controls
Activity Summary, and either a 510(k) Summary or 510(k) Statement.
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test,
a microhematocrit analyzer that, among other intended uses, can determine the hematocrit
of a blood donor prior to donation of a blood product. The firm should address the 510(k)
submission to:
A. CDER
B. CBER
C. CDRH
D. OCP
B. CBER
In this case, the firm should submit the 510(k) to CBER (Center for Biologics Evaluation and
Research) because the microhematocrit analyzer is intended for use in determining the
hematocrit of blood donors, which relates to the safety of blood and blood products. CBER is
responsible for regulating biologics, including blood and blood products, so this falls under their
jurisdiction.
A company is planning to implement a few minor manufacturing changes for its FDA-
approved device. The company is currently conducting a clinical study for a new indication
using this device. The correct submission for the regulatory professional to make is the
A. PMA Amendment
B. IND Supplement
C. IDE 5-day Notice
D. CBE-30
C. IDE 5-day Notice
When a company is conducting a clinical study under an approved Investigational Device
Exemption (IDE) and plans to implement minor manufacturing changes to the device being
,studied, they must notify the FDA. For minor changes, the company typically submits an IDE 5-
day Notice before making the changes.
PMA Amendment: Used for changes to a device with an approved Premarket Approval (PMA),
not during an IDE.
IND Supplement: Applies to drugs or biologics under an Investigational New Drug (IND)
application, not devices.
A company begins to market its new device, a pacemaker (Class III) the same day its
regulatory professional submits the Premarket Approval Application (PMA) to FDA. The
pacemaker is considered:
A. Legally marketed
B. Misbranded
C. Investigational
D. Adulterated
D. Adulterated
Marketing a Class III device, such as a pacemaker, before receiving Premarket Approval (PMA)
from the FDA is illegal. As a result, the device is considered misbranded because it lacks the
required approval for marketing. Under FDA regulations, a device must have proper labeling and
necessary approvals before it can be legally marketed.
Legally marketed: Incorrect, as the device is marketed without FDA approval.
Investigational: Incorrect, because it is being marketed, not investigated under an IDE.
A company is developing a new device, and the device classification under which it would
fall is not clear. As the regulatory professional, you would make the following submission:
A. 510(k) Premarket Notification
B. Request for Designation
C. 513(g) Request for Information
D. Type A Meeting Request
C. 513(g) Request for Information
When the device classification is unclear, a regulatory professional would submit a 513(g)
Request for Information to the FDA. This request allows the company to seek information
from the FDA regarding the classification of the device and the regulatory requirements that
would apply.
510(k) Premarket Notification: Used when the classification and predicate device are known.
Request for Designation: Typically used for combination products to determine which FDA
center will lead the review.
Type A Meeting Request: This is specific to drugs or biologics and involves meetings with the
FDA for ongoing regulatory issues or guidance.
,The document required by the Quality System Regulation (QSR) that tracks each device's
manufacture by unit, lot and batch is the:
A. Device Master Record
B. Device History Record
C. Design History File
D. Device Master File
B. Device History Record
The Device History Record (DHR) is required by the Quality System Regulation (QSR) and
contains information that tracks the manufacturing history of each device by unit, lot, or batch. It
ensures that the device was manufactured according to the specifications in the Device Master
Record (DMR).
Device Master Record (DMR): Contains the specifications and instructions for manufacturing
the device but does not track individual production units.
Design History File (DHF): Documents the design and development of the device.
Device Master File (DMF): Not a regulatory requirement under QSR and is typically used for
drug master files, not device manufacturing tracking.
You are the regulatory expert in a small start-up medical device company. A clinical
investigation is required for your Class II medical device 510(k) submission. One of the
investigators who conducts the study also has received 1,000 stock options from your
company as part of his consulting agreement. What information related to this investigator
must be included with your 510k submission?
A. Form 3454, certifying lack of financial interests and arrangements
B. Form 3455, disclosing the stock options for the specific investigator
C. Form 3455, disclosing proprietary interest in the tested product
D. No additional forms are required
B. Form 3455, disclosing the stock options for the specific investigator
In this case, since the investigator has received stock options from your company, this constitutes
a financial interest that must be disclosed. Form 3455 is used to disclose such financial
arrangements, including stock options, which could potentially affect the outcome of the clinical
study.
Form 3454 is used when there are no financial interests to disclose, which does not apply here.
No additional forms are required would be incorrect because the stock options represent a
financial arrangement that needs to be reported.
Form 3455, disclosing proprietary interest in the tested product would be correct if the
investigator had proprietary interest in the device itself; however, in this case, the stock options
pertain to financial interest, so Form 3455 must still be used.
, The quality assurance manager of a small company with 12 employees is the company's
only internal auditor and has been performing all internal quality system audits for three
years. This does not meet the requirements for performing internal quality systems audits
because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality assurance manager in
quality auditing principles
C. Quality system audits cannot be performed by the same auditor for more than two
audits in a row
D. The Audit Reports need to be approved by a second internal auditor not involved with
the specific audit
A. Auditor independence has not been ensured
In quality management systems, including those under the Quality System Regulation (QSR) or
ISO 13485, auditor independence is a key requirement. An internal auditor must be
independent of the areas they are auditing to avoid conflicts of interest and ensure objective
assessments. Since the quality assurance manager is the only internal auditor and has been
conducting all audits for three years, their independence cannot be guaranteed, especially if they
are auditing areas they oversee.
The other options are not explicitly required by the regulations: There's no requirement that
someone else must train the auditor within the company. There's no limit on the number of
consecutive audits by the same auditor. Audit reports do not necessarily need to be approved by
a second internal auditor; the critical issue is the auditor's independence.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis
after treatment with an approved device. This side effect is not listed in the package insert.
This event must be reported by the manufacturer to FDA no later than:
A. 5 calendar days after receipt or becoming aware of information
B. 15 calendar days after receipt or becoming aware of information
C. 30 calendar days after receipt or becoming aware of information
D. The next quarterly report
C. 30 calendar days after receipt or becoming aware of information
Question Feedback
Serious injury must be reported within 30 days; see 21 CFR 803.50(a)
For medical devices, a serious injury must be reported within 30 days after receipt or becoming
aware of information, whether or not it is expected and stated in the IFU.
You work for a German-based device manufacturer that packages the device in Ireland
and sells the product in the US through a US-based company. The 510(k) was written by a
