DEVICE RAC
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DEVICE RAC EXAM QUESTIONS AND
ANSWERS| VERIFIED ANSWERS 2022-2023
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP [Correct Ans: – C
A company wants to modify its legally marketed device such that the modification does not affect
the intended use or alter the fundamental scientific technology of the device. If the design outputs
of the modified device meet the design input requirements, this change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) [Correct Ans: – A
Under the statutory violations, failure to meet 510(k) requirements for a device that is required to
have a 510(k) and is in commercial distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent [Correct Ans: – C
A company’s competitor is marketing a Class II suture which dissolves during the third week of use.
The company’s current product has to be removed by a physician. However, a change in weaving
configuration gives this product the same dissolving time as the competitors. When can the
company’s new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report<\/p>\n\n\n\n
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D. After submission of labelling change [Correct Ans: – A
Which of the following is exempt from GMP\/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackages
D. Component manufacturers [Correct Ans: – D
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
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report [Correct Ans: – C
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 typically occurs?
A. The labelling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A “Dear Doctor” letter is issued. [Correct Ans: – A
A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life [Correct Ans: – C
You have modified your 510(k) cleared device with a special 510(k). In which of the following cases
would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.<\/p>\n\n\n\n
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B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. [Correct Ans: – D
According to the QSR, when an investigation of a complaint is conducted all of the following are
requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant [Correct Ans: – C
The QSR calls for the manufacturer of finished devices to carry out all of the following EXCEPT:
A. Conduct quality audits by individuals who do not have direct responsibility for the operation being
audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited [Correct Ans: – B
Which of the following subsystems is NOT required by FDA in order to implement and maintain a
Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls [Correct Ans: – B
According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices
after rework activities must be documented in the:
A. Device history record
B. Device master record
C. Quality manual
D. Design history file [Correct Ans: – A<\/p>\n\n\n\n
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RAC device Quiz Questions With
Complete Solutions 2023-2024
EU: Which of the following does NOT describe the CE Mark or its use?
A) The CE Mark is an external indication that a device meets the Essential
Requirements
B) The manufacturer and\/or the Notified Body have checked the device against
specifications using a ConformityAssessment Procedure
C) A Declaration of Conformity has been produced by the manufacturer
D) The CE Mark allows the device to move freely throughout Europe only
[Ans: – D) The CE Mark allows the device to move freely throughout Europe only
EU: The following are components of routine risk minimisation EXCEPT:
A) Adding protective measures in the manufacturing process
B) Application of relevant standards
C) An evaluation of the need for risk minimisation activities
D) A marketing plan
[Ans: – D) A marketing plan
EU: Classification of medical devices is based upon all of the following EXCEPT
the:
A) Device’s intended purpose
B) Device’s implantability
C) Devise invasiveness
D) Device’s indications for use
[Ans: – D) Device’s indications for use
Note: MDR Chapter V Article 51: “Devices shall be divided into classes I, IIa, IIb and
III, taking into account the intended purpose of the devices and their inherent risks”<\/p>\n\n\n\n
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EU: Which of the following does NOT describe a “custom device\u201d?
A) It is made specifically in accordance with a duly qualified medical practitioner’s
written prescription, which gives specific design characteristics
B) The manufacturer and\/or the Notified Body have checked the device against
specifications using a Conformity Assessment Procedure
C) It is intended for the sole use of a particular patient
D) The device cannot exhibit the CE Mark to move freely throughout Europe
[Ans: – B) The manufacturer and\/or the Notified Body have checked the device
against specifications using a Conformity Assessment Procedure
MDR: ‘custom-made device’ means any device specifically made in accordance with
a written prescription of any person authorised by national law by virtue of that
person’s professional qualifications which gives, under that person’s responsibility,
specific design characteristics, and is intended for the sole use of a particular
patient exclusively to meet their individual conditions and needs.
Your US-based company has a medical device manufacturing site in the
Netherlands. It wishes to relocate that facility to Belgium. Which of the following
BEST describes the actions required?
A) No regulatory actions are required to move facilities within the EU
B) A site audit of the new facility based on ISO 13485:2003 requirements will be
necessary to ensure the Essential Requirements continue to be met
C) Product labelling revisions may be required
D) You must obtain new Certificates of Free Sale from Belgium to ship product from
the new facility to other EU countries
[Ans: – B) A site audit of the new facility based on ISO 13485:2003 requirements will
be necessary to ensure the Essential Requirements continue to be met
The development team approaches you concerning the registration strategy and
marketing application for a combination product involving inhaled device
delivery of a small medicinal molecule. In the US, this product will be treated as
a drug and submitted in a New Drug Application (NDA). In Europe, the
registration approach may include all of the following EXCEPT a:<\/p>\n\n\n\n
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RAC Medical Devices Exam Questions
and Answers With Complete Solutions
A Special 510(k) relies on the following information:
a) Design control documentation
b) Guidance documents
c) Consensus standards
d) All of the above
[Ans: – d) All of the above
A Special 510(k) verifies and validates that a device meets Design Controls by all of
the following EXCEPT:
A. Ensuring that design outputs meet design inputs
B. Ensuring that devices conform to defined user needs and intended uses
C. Conforming to the QS Regulation, CFR Part 820
D. Claiming substantial equivalence to a competitor device
[Ans: – D. Claiming substantial equivalence to a competitor device
(For a Special 510(k), you must claim equivalence to the applicant’s own marketed
device).
A design or labeling change to an existing device (including certain changes to the
indications for use) may be appropriate for a Special 510(k) when:
A. The proposed change is submitted by the manufacturer legally authorized to
market the existing device,
B. Performance data are unnecessary, or if performance data are necessary, wellestablished methods are available to evaluate the change, and
C. All performance data necessary to support substantial equivalence can be
reviewed in a summary or risk analysis format
D. All of the above
[Ans: – D. All of the above
FDA believes that well-established methods for a Special 510(k) may include which
of the following:<\/p>\n\n\n\n
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A. Lesser-known test methods that can be proven effective by the manufacturer
B. Methods found in an FDA-recognized voluntary consensus standard or FDA
guidance document
C. Full test reports including methods
D. Methods found acceptable by FDA through a competitor’s 510(k)-clearance or
premarket application (PMA) approval
[Ans: – B. Methods found in an FDA-recognized voluntary consensus standard or
FDA guidance document
Device manufacturers may choose to submit an Abbreviated 510(k) when the
submission relies on any of the following EXCEPT:
A. FDA guidance document(s)
B. Design Control validation and verification
C. Demonstration of compliance with special controls for the device type, either in a
device-specific classification regulation or a special controls guidance document
D. Voluntary consensus standard(s)
[Ans: – B. Design Control validation and verification
If you are submitting a 510(k) to FDA that includes a summary of compliance with
special controls, you are submitting a:
A. Special 510(k)
B. Traditional 510(k)
C. Abbreviated 510(k)
D. de novo 510(k)
[Ans: – C. Abbreviated 510(k)
(an Abbreviated 510(k) includes a summary report illustrating compliance to special
controls or alignment with guidance documents or voluntary consensus standards)
If you are including in your 510(k) a declaration of conformity with voluntary
consensus standards, you are submitting a:
A. Special 510(k)
B. Traditional 510(k)
C. Abbreviated 510(k)
D. Any of the above<\/p>\n\n\n\n
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RAC Practice Exam 1 2023-2024 Questions
With Complete Solutions| Verified Answers
Which of the following is NOT required for compliance under 21 CFR Part 11
(electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of
operator entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify or
delete electronic records.
D Establishment of and adherence to written procedures [Ans: – A.
The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the:
[Ans: – Institutional Review Board (IRB)
A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug
product that varies from the Reference Listed Drug (RLD) in route of
administration, dosage form, or strength, but anticipates that the labeling will be
identical to that of the RLD. What process should be used to apply for that
permission from FDA?
[Ans: – Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to
market a
[Ans: – New chemical entity when the sponsor has a right of reference to all
applicable published studies
Distribution records for drug products must reference or contain:
[Ans: – Name and address of the consignee
A mid-sized pharmaceutical company negotiated with FDA to submit a draft
Package Insert (PI) and patient medication guide (MedGuide) in annotated Word
format for initial FDA review, and committed to submit the Labeling in Structured
Product Label<\/p>\n\n\n\n
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(SPL) format upon approval of their product. What is the preferred timeline for this
pharmaceutical company to submit the SPL formatted labeling upon product
approval?
[Ans: – 14 days
Adverse event reporting for a marketed biologics product is NOT required for:
[Ans: – Diagnostic non-invasive test kits
The quality assurance manager of a small company consisting of 12 employees is
the only internal auditor for the company 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
[Ans: – Auditor independence has not been ensured.
You have modified your 510(k)-cleared device with a Special 510(k). In which case
would a Special 510(k) not be appropriate for the device?
[Ans: – You have changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption?
[Ans: – Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in
the field. The device has an expiration date indicated on its labeling. A sales person
notes that one of his products has expired and contacts the headquarters office for
direction. He is told to return the product to the headquarter office for
replacement. The return of this product is considered as what type of recall?
[Ans: – Not a recall\u2014it is considered normal stock rotation
A company is developing an (unapproved) drug-device combination product but is
not sure to which center it should submit its marketing application. The company
should first submit
[Ans: – A Request for Designation to the Office of Combination Products
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by
FDA. What is the most appropriate regulatory pathway?<\/p>\n\n\n\n
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[Ans: – A Request for Designation (RFD) should be sent to the Office of
Combination Products (OCP) at FDA to determine the primary mode of action
(PMOA) and assign the agency with primary jurisdiction.
FDA’s Office of Generic Drugs (OGD) remains committed to the “first-in, firstreviewed” review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a specific
reason to expedite an application. What is NOT a specific reason to grant expedited
review?
[Ans: – Products that show evidence of safety and effectiveness in a new
subpopulation
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:
[Ans: – CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards [Ans: – C
What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)?
[Ans: – Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the
investigational plan. When a meeting request is received by FDA, the meeting will be
held within 30 days. The agreements made at the meeting are provided in writing to
the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration
Meetings Under the FDA Modernization Act; Final Guidance for Industry and for
CDRH Staff (February 2001).
A US medical device contract manufacturer has customers for whom it
manufactures medical device components (parts) and finished medical devices. To
date, all products have been either parts for Class II medical devices or Class II
finished medical devices. The manager of new business contacts the regulatory
manager to assess the impact of a possible new customer involving a Class III<\/p>\n\n\n\n
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RAC Practice Exam 2 Questions and
Answers| Verified Answers
You work for a German-based device manufacturer (Company A) that produces a power supply
based on a US-based medical device company’s (Company B) design. The power supply is imported
into your company’s US-based manufacturing site (Company C) for further processing and then sent
to the US-based medical device company (Company B) for final assembly. Which company needs to
register with FDA:
A. Company A
B. Company B
C. Company A &B
D. Company A, B &C [Ans: – B.
Company A qualifies as a foreign component manufacturer and as such, does not require
establishment registration under 21 CFR 807.65(a).
Company C is the initial imported of a component and does not need register under 21 CFR 807.20.
The following biological products are regulated by CBER EXCEPT:
A. Immunizing toxoids
B. Monoclonal antibodies for in vitro use
C. Monoclonal antibodies for in vivo use
D. Infusion of animal sourced cells into a human [Ans: – C.
PHS Act Section 351(a)
SOPP 8001.5 Intercenter Consultative\/Collaborative Review Process
Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research
http:\/\/www.fda.gov\/CombinationProducts\/JurisdictionalInformation\/ucm136265.htm
(http:\/\/www.fda.gov\/CombinationProducts\/JurisdictionalInformation\/ucm136265.htm)<\/p>\n\n\n\n
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Monoclonal antibodies for in vivo use were transferred to CDER’s Office of New Drugs (OND)
effective 30 June 2003
A company is developing a new device and the classification under which it would fall is unclear. As
the regulatory professional, you would submit the following:
A. 510(k) Premarket Notification
B. Request for Designation
C. 513(g) Request for Information
D. Type A Meeting Request [Ans: – C.
A 513(g) Request for Information is submitted to ask FDA to determine a device’s classification and
applicable requirements under the FD&C Act.<\/p>\n\n\n\n
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http:\/\/www.fda.gov\/OHRMS\/DOCKETS\/98fr\/02d-0525gdl00001.PDF
(http:\/\/www.fda.gov\/OHRMS\/DOCKETS\/98fr\/02d-0525gdl00001.PDF)
Guidance for Industry: Immediate Release Solid Oral Dosage Forms
http:\/\/www.fda.gov\/downloads\/Drugs\/Guidances\/UCM070636.pdf
(http:\/\/www.fda.gov\/downloads\/Drugs\/Guidances\/UCM070636.pdf)
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm124826.htm
(http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm124826.ht
m)
Product release and disposition is a quality responsibility, not regulatory. The regulatory professional
is responsible for reviewing the event and assessing whether the additional steps performed in the
manufacturing process are allowed within the regulatory filing. The team may decide to include the
rework procedure; however, additional data may be needed for the submission. Therefore the
recommended first step is response 3.
A company’s competitor is marketing a Class II suture that dissolves during the third week of use.
The company’s current product has to be removed by a physician. However, a change in weaving
configuration gives this product the same dissolving time as the competitor’s. What needs to be
done for the company to market this new dissolving suture?
A. Filing a new 510(k) documenting changes in product instructions for use
B. Submission of changes in a periodic report
C. After-reporting clinical studies in an Annual Report
D. After-submission of labeling change [Ans: – A.
A new intended use requires a 510(k).
While reviewing product complaint files for MDR reportability, you notice a complaint regarding a
common failure mode of an implantable screw. No patient involvement or adverse consequences
were reported in the complaint. Your firm has initiated a Class I recall for this implantable screw due
to safety issues associated with this failure mode. As a regulatory professional your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode likely will cause or
contribute to death or serious injury<\/p>\n\n\n\n
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C. No MDR is needed as there is no patient involvement and no adverse consequences were
reported
D. No MDR is needed but you will file this complaint in the recall file [Ans: – A.
When a recall is initiated for a particular product failure mode, such failure mode automatically is
MDR-reportable to FDA. Additionally, while the complaint did not report an adverse event, the
manufacturer should evaluate the potential to cause an adverse event if the failure mode was to reoccur.
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k) [Ans: – D.
IVDs could be submitted as a 510(k) under the FD&C Act or a BLA under the PHS Act.
http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm123
682.htm
(http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm12
3682.htm)
Regulatory Authority: IVDs are “medical devices” as defined in Federal Food, Drug, and Cosmetic Act
Section 210(h) or biological products subject to Public Health Service Act Section 351.
The two mechanisms to amend an OTC Monograph are:
A. Time & Extent Application (TEA) or Annual Report
B. Time & Extent Application (TEA) or Citizen Petition
C. Annual Report or Preapproval Supplement
D. Citizen Petition or Preapproval Supplement [Ans: – B.
21 CFR 10.30, 21 CFR 330.14, Regulation of Non-Prescription Drug Products ODE-IV (Slide 23 to 25)
located at http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/CDER\/UCM148055.pdf
(http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/CDER\/UCM148055.pdf)<\/p>\n\n\n\n
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RAC Exam Practice Latest Questions
and Answers\/Complete Solutions
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938?
a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for
unavoidable poisonous substances(1:1) [Ans: – A: Proof of efficacy
Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey
Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver-Harris Amendments
(1:2) [Ans: – D: Kefauver-Harris Amendments
The Color Additive Amendment of 1960 required FDA to prove that a color additive was unsafe
before removing it from the market. a) True b) False(1:3) [Ans: – B: False
What has been described as “the most extensive change to the agency’s practices since 1938?” a)
Prescription Drug User Fee Act of 1922b) GMPs for the 21st Century initiative c) Food and Drug
Administration Modernization Act d) Food and Drug Administration Amendments Act(1:4) [Ans: – C:
Food and Drug Administration Modernization Act
Both regulations and guidance documents have the force of law. True or False?(2:1) [Ans: – False.
Only regulations have the force of law.
Although FDA’s statutory authority does not extend to the occupational safety and health
responsibilities of OSHA the agencies coordinate their efforts in matters of related responsibility
such as unshielded syringes and natural rubber latex. True or False?(2:2) [Ans: – True
An FDA petition much contain which of the following? a) Action requested b) Statement of grounds
c) Environmental impact d) All of the above(2:3) [Ans: – D: All of the above
Drugs may be eligible for over-the-counter status when: a) They have been marketed to a material
extent b) They have been marketed for a material time c) Are generally recognized as safe d) All of
the above(2:4) [Ans: – D: All of the above<\/p>\n\n\n\n
RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC RAC DEVICE RACbestmaxsolutions1DEVICE RAC EXAM QUESTIONS ANDANSWERS| VERIFIED ANSWERS 2022-2023Which division would have primary jurisdiction over a vascular graft with an antibiotic based onprimary mode of action?A. CDERB. CBERC. CDRHD. OCP [Correct Ans: – CA company wants to modify its legally marketed device such that the modification does not affectthe intended use or alter the fundamental […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[25],"tags":[],"class_list":["post-118043","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/118043","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/comments?post=118043"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/118043\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=118043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=118043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=118043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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Biologics are cleared for marketing through which process ?a) Establishment License Application
(ELA)b) Product License Application (PLA)c) Biologics License Application (BLA)d) All of the above(2:5)
[Ans: – C: Biologics License Application (BLA)
A Special 510(k) relies on the following information: a) Design control documentation b) Guidance
documents c) Consensus standards d) All of the above(2:6) [Ans: – A: Design control documentation
Which act required rulemaking meetings to be open to the public? a) Moonshine Act b) Government
in the Sunshine Act c) Food Drug and Cosmetics Act d) Administrative Amendments Act(2:7) [Ans: –
B: Government in the Sunshine Act
Which of the following does not distinguish the development of drugs for animal use from those for
human use: a) The ability to use known data from the development of a drug for use in humans or
other animal species as applicable. b) Generally safety and efficacy studies require only 10s of
animals per group compared to the 100s of patients per group required for human drugs. c) Does
not have user fees for NADAs. d) Species class and breed of animals as well as geographical
differences are more relevant.(3:1) [Ans: – C: Does not have user fees for NADAs.
A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90%
confidence intervals for the ratio of population geometric means between the two treatments based
on log-transformed data is contained within the equivalence limits of % – <\/em><\/strong>% for AUC and
Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) [Ans: – D: 80% and 125%
What is the definition of a biologic?(3:3) [Ans: – A substance derived from or made with the aid of
living organisms.
What are the major categories of ICH guidelines?(3:4) [Ans: – Quality Safety Efficacy
Multidisciplinary
What is the deadline for an initial IND Safety report of a fatal or life-threatening serious adverse
event?(3:5) [Ans: – 7 days
FDA promulgates regulations in which of the following? a) Code of Federal Regulations b) Docket
Management System c) Federal Register d) Federal Docket(4:1) [Ans: – C: Federal Register
What five types of application meetings are available to sponsors submitting medical devices to
CDRH?(4:2) [Ans: – Agreement Determination Pre-IDE Pre-PMA and PMA day-100<\/p>\n\n\n\n
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Under what circumstances is it appropriate to request a Type A meeting?(4:3) [Ans: – The Type A
meeting is one that is immediately necessary for an otherwise stalled drug development program to
proceed. Type A meetings are reserved for dispute resolution discussion of clinical holds and special
protocol assessment meetings.
True or False: A hearing to review the safety and efficacy of an NDC is a public hearing before the
commissioner. (4:4) [Ans: – False. A hearing to review the safety and efficacy of an NDA is a public
hearing before a public advisory committee.
True or False: FDA advisory committee meetings may be completely closed to the public and notice
of a meeting is not required to be published until the day of the meeting. (5:1) [Ans: – False:
Advisory committee meetings may be closed but no advisory committee meeting can be completely
closed (21 CFR 14.27)
True or False: FDA advisory committees provide independent expert advice and credibility to
product reviews. (5:2) [Ans: – True
Where can you find guidance on the time frames for preparing briefing materials for an advisory
committee meeting?(5:3) [Ans: – “Guidance for Industry Advisory Committee Meetings –
Preparation and Public Availability of Information Given to Advisory Committee Members (August
2008)”
True or False: There are 31 advisory committees within FDA.(5:4) [Ans: – True
Industry representatives are\/are not voting members of an advisory committee because they are
independent of the sponsor company and represent the industry as a whole.(5:5) [Ans: – Industry
members are non-voting members of an advisory committee. (21 CFR 14.84)
Stability testing of clinical trial materials and commercial drug products is subject to: a) Good
Laboratory Practice Regulations b) Good Scientific Practice Regulations c) Good Manufacturing
Practice Regulations d) Both a and b e) None f) All of the above(6:1) [Ans: – C: Good Manufacturing
Practice Regulations
True or False: Good Laboratory Practice Regulations require the Quality Assurance Unit to prepare a
GLP Compliance Statement for inclusion in the final study report(6:2). [Ans: – True<\/p>\n\n\n\n
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US RAC Review Questions RAPS Modules With Complete
Solutions (Latest Update 2023|Verified Answers
In which situation is an IND not required?
A) You intend to conduct a clinical trial with an investigational new drug
B) You intend to conduct a clinical trial with an approved drug to support a marketing application for
a new indication
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic
information
D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination
[Ans: – C) You intend to collect blood samples from subjects to look for biomarkers or
pharmacogenetic information
In the clinical development plan for an investigational antihypertensive drug, which of the
following studies would typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
D) Single dose escalation study in hypertensive patients
[Ans: – B) Single dose escalation PK study in healthy volunteers
A sponsor must report an unexpected, fatal or life-threatening experience believed to be
associated with an unapproved drug\/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days
[Ans: – B) to FDA and investigators within 7 calendar days<\/p>\n\n\n\n
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Which of the following is a covered study as defined under Financial Disclosure regulations?
A) Phase I dose escalation study
B) Phase I\/II Pharmacokinetic Study
C) A large open label safety study conducted at a large number of study sites
D) Phase III pivotal study
[Ans: – D) Phase III pivotal study
Your company is developing a product to treat a serious and life-threatening disease. A clinically
meaningful, well established primary endpoint will be used in the pivotal studies. Which
regulatory strategy might you select prior to commencing Phase 3 studies?
A) Request Special Protocol Assessment
B) Request Fast Track Designation
C) Request Priority Review
D) Approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening
Illnesses
[Ans: – A) Request Special Protocol Assessment
As a regulatory affair professional, you are responsible for developing the content of an
information package for a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team members
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary
[Ans: – B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
You, a regulatory affair professional, are assessing the information to be submitted in support of a
marketing application for a new dosage form for a listed drug. You lack right of reference to one
key preclinical report. Which type of application will you prepare for submission?
A) 505 (b) (1)<\/p>\n\n\n\n
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B) 505 (b) (2)
C) 505 (j)
D) PMA
[Ans: – B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy, which of the following is a possible
outcome?
A) Defer review of pending application(s)
B) “File” a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application
[Ans: – A) Defer review of pending application(s)
9) Which of the following supplements to an approved NDA\/BLA must be approved by FDA prior
to distributing product made using the change?
A) Make change(s) to comply with USP
B) Change in the technical grade of an excipient, same
specifications and use
C) Add a warning statement to prescribing information
D) Process change outside the validated range
[Ans: – D) Process change outside the validated range
10) Which of the following products would not be regulated by CDER?
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies
[Ans: – B) Vaccines<\/p>\n\n\n\n
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RAC Sample Test 2023-2024 Questions
with All Correct Answers + Feedback
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labelling specifications
C. Design reviews
D. Calibration records [Correct Ans: – B. Labeling specifications
Question Feedback: Labelling specifications are part of the DMR
A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous
GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy
and have been published in peer-reviewed journals. The most-appropriate method to gain approval
would be by filing a:
A. ANDA
B. SNDA
C. 505(b)2
D. 505(b)1 [Correct Ans: – C. 505(b)2
Question Feedback: Since the drug has been studied and those results published, a comparability
study between IV and oral dosage forms is acceptable under a 505(b)2
Your company is considering a new drug product. It has been on the market for more than 30 years
in a foreign country, but has never been approved in the US. To sell this product in the US, you may
do the following immediately EXCEPT:
A. Determine monograph or NDA status of the product
B. Initiate clinical studies in the foreign country to support the claims since the clinical data are old
and would not meet current requirements
C. Determine whether this is a New Chemical Entity
D. Import the product and use new labelling [Correct Ans: – D. Import the product and use new
labelling<\/p>\n\n\n\n
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Question Feedback: The importation of a drug product to be distributed in the US must meet US
regulations, regardless of its approved status in another country, therefore answer 4 is correct.
A company is developing a combination product consisting of a device that injects a specially
formulated small molecule drug for pain into the muscle tissue. Which of the following describes the
best US regulatory path?
A. The product is regulated as a drug
B. The product is regulated under CDRH
C. The company should file a BLA to obtain US marketing approval
D. The company should submit a request for designation to OCP [Correct Ans: – A. The product is
regulated as a drug
Question Feedback: Primary mode of action is the pain drug and the device is a delivery system
FDA has issued a Complete Response Letter to a company. The company views many of the
deficiencies as minor. The regulatory professional should meet with the team to:
A. Devise a strategy for responding to all deficiencies identified by FDA
B. Devise a strategy to respond to any minor deficiencies in order to restart the review clock
C. Inform the team a Class 1 resubmission has a six-month review clock
D. Inform the team a Class 2 resubmission has a three-month review clock [Correct Ans: – A. Devise a
strategy for responding to all deficiencies identified by FDA
Question Feedback: Resubmission\u2019s purport to answer all of the deficiencies needing to be
addressed by the applicant prior to the original application’s approval as set forth in a previous
action letter.
A drug manufacturer creates a game-based simulation to assist diabetes patients with management
of their blood glucose levels and to motivate them to adhere to their medication schedules. The
game will be based on a password protected website that will be made available to patients when an
FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will be regulated as a Class I medical device
C. It will be regulated as an in vitro diagnostic product
D. It will not be an FDA regulated product [Correct Ans: – D. It will not be an FDA regulated product<\/p>\n\n\n\n
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Question Feedback: This type of “advertising” would fall under the category of a “help-seeking”
advertisement because the product is not named, although it likely makes recommendations about
actions that might be taken based on a particular symptom, i.e., low or elevated glucose levels.
Unlike drug and device promotional labeling and prescription drug and restricted device advertising,
disease awareness communications are not subject to the requirements of the FD&C Act and FDA
regulations.
For which device below does the Quality System Regulation require the same procedures for
identifying the control number for each unit, lot or batch of finished devices as those mandated by
the new UDI Rule?
A. Surgical gloves
B. X-ray machines
C. Pacemakers
D. Syringes [Correct Ans: – C. Pacemakers
Question Feedback: According to 21 CFR 820.65,”Each manufacturer of a device that is intended
for surgical implant into the body or to support or sustain life and whose failure to perform when
properly used in accordance with instructions for use provided in the labeling can be reasonably
expected to result in a significant injury to the user shall establish and maintain procedures for
identifying with a control number each unit, lot, or batch of finished devices and where appropriate
components.” The Pacemaker is a Class III implantable device and subject to 21 CFR 820.65. (Sec.
820.65 Traceability- Each manufacturer of a device that is intended for surgical implant into the body
or to support or sustain life and whose failure to perform when properly used in accordance with
instructions for use provided in the labeling can be reasonably expected to result in a significant
injury to the user shall establish and maintain procedures for identifying with a control number each
unit, lot, or batch of finished devices and where appropriate components. The procedures shall
facilitate corrective action. Such identification shall be documented in the DHR.)
Your company is developing a new drug to be developed and used in combination with a cystoscopic
light device for the early detection of bladder cancer. You are asked to develop an overall regulatory
strategy. The first step you undertake is:
A. Submit a Request for Designation to FDA Office of Combination Products for determination of the
lead center for primary jurisdiction for the combination product.
B. Make a preliminary internal company determination of the combination product’s primary
mode of action.
C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug
Products (OODP).
D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products
[Correct Ans: – B. Make a preliminary internal company determination of the combination product’s
primary mode of action.<\/p>\n\n\n\n
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Question Feedback: It is important to determine the primary mode of action first to be able to
make a recommendation as to which agency component should have primary jurisdiction, to be
followed by a request for designation to FDA OCP if deemed necessary when the product’s
classification or the agency center to which it should be assigned in unclear or in dispute.
A key pharmaceutical product parameter has a specification range of 90-100. Which of the following
postmarketing specification changes would require FDA notification prior to making the change?
A. 89-100
B. 90-99
C. 95 +\/- 5
D. 95-100 [Correct Ans: – A. 89-100
Question Feedback: Notification is required when the specification range is widened. VIII.
Specifications: B. Major Changes (Prior Approval Supplement) The following are examples of changes
in specifications considered to have a substantial potential to have an adverse effect on the identity,
strength, quality, purity, or potency of a drug product as these factors may relate to the safety or
effectiveness of the drug product. C. Moderate Changes (Supplement\u2014Changes Being Effected)
Supplement\u2014Changes Being Effected in 30 Days b. Relaxing an acceptance criterion
Which of the following statements is NOT true for Phase I Investigational New Drug (IND)
Applications and Investigational Device Exemptions (IDEs) for significant-risk products?
A. The investigational product must be manufactured in full compliance with CGMP
B. Clinical study protocols must be reviewed and approved by an Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the
sponsor otherwise
D. The application must include an environmental impact statement that contains a claim for
categorical exclusion or an environmental assessment [Correct Ans: – A. The investigational product
must be manufactured in full compliance with CGMP
Question Feedback: According to CFR 210, 2(c), “An investigational drug for use in a phase 1 study,
as described in 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21
U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in
part 211 of this chapter.” However, based on FDA guidance, Phase 1 investigational drugs should be
manufactured with the application of some (not full) CGMP.<\/p>\n\n\n\n
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US RAC Practice Exam Latest Questions With
Complete Solutions| Verified Answers
[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key
parameters of the investigational plan for a Class III device?
[A] Agreement meeting
[B] Determination meeting
[C] Presubmission meeting
[D] PMA Day-100 meeting [Ans: – [A] Agreement meeting
[Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product
development program to proceed?
[A] Type A
[B] Type B
[C] Type C
[D] Type D [Ans: – [A] Type A
[Q]Which type of meeting is held with the FDA for a Special Protocol Assessment?
[A] Type A
[B] Type B
[C] Type C
[D] Type D [Ans: – [A] Type A
[Q]Within how many days after FDA’s receipt of a written request for a meeting should the following
meetings occur: Type A, Type B, Type C
[A] 15, 30, 45
[B] 30, 45, 60
[C] 30, 60, 90
[D] 30, 60, 75 [Ans: – [D] 30, 60, 75
[Q]How often does a drug product listing need to occur?
[A] Annually<\/p>\n\n\n\n
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[B] Every June and December
[C] Quarterly
[D] Once [Ans: – [B] Every June and December
[Q]Upon receipt of a complete PMA, how many days does the FDA have to approve or not approve
the PMA?
[A] 90
[B] 120
[C] 150
[D] 180 [Ans: – [D] 180
[Q]What is the one section that is required in an NDA but not in a BLA?
[A] CMC
[B] Clinical data
[C] Field copy certification
[D] Microbiology [Ans: – [C] Field copy certification
[Q]What are the possible outcomes to a PMA?
[A] Approval, unacceptable, refusal
[B] Acceptance, pending, rejected
[C] Approval, Approvable, not approvable, denial
[D] Approval letter, complete response letter, refuse to file letter [Ans: – [C] Approval, Approvable,
not approvable, denial
[Q]What are the possible outcomes to an NDA?
[A]Approval, unacceptable, refusal
[B]Approval letter, complete response letter, refuse to file letter
[C]Approval, not approvable, denial
[D]Acceptance, pending, rejected [Ans: – [B]Approval letter, complete response letter, refuse to file
letter
[Q]What is the approval timeline for a priority NDA versus a standard NDA?<\/p>\n\n\n\n
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[A] 10 months, 12 months
[B] 6 months, 10 months
[C] 6 months, 12 months
[D] 12 months, 18 months [Ans: – [B] 6 months, 10 months
[Q]A new drug is any drug not generally recognized as safe and effective before . [A] 1964 [B] 1948 [C] 1927 [D] 1938 [Ans: – [D] 1938 [Q]A 510 (k) is required for<\/em><\/strong> Class I devices and _ Class II devices. [A] Some, most [B] All, all [C] All, most [D] Most, some [Ans: – [A] Some, most [Q]Which 510 (k) do you file where a guidance document exists that provides reasonable assurance that the device’s safety and effectiveness have been established? [A] Traditional [B] Standard [C] Abbreviated [D] Special [Ans: – [C] Abbreviated [Q]Which 510 (k) do you file where the device modification does not affect its intended use? [A] Traditional [B] Standard [C] Abbreviated [D] Special [Ans: – [D] Special [Q]A determination of substantial equivalence to a 510 (k) implies <\/em><\/strong>to market the device,
not _<\/em><\/strong><\/em> to market the device.<\/p>\n\n\n\n
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[A] Approval, clearance
[B] Clearance, approval
[C] Permission, approval
[D] Clearance, notification [Ans: – [B] Clearance, approval
[Q]If the FDA requests additional information while reviewing a 510 (k) submission, you have _<\/em>
days to respond.
[A] 30
[B] 60
[C] 90
[D] 180 [Ans: – [D] 180
[Q]Which of the following are exempt from premarket notification?
[A] Custom devices
[B] Special devices
[C] Restricted devices
[D] None of the above [Ans: – [A] Custom devices
[Q]Form FDA , Blood Establishment Registration and Product Listing, is used for submission of registration and product listing information to the FDA. [A] 4030 [B] 2830 [C] 3356 [D] 1170 [Ans: – [B] 2830 [Q]Completion of Form FDA<\/em><\/strong> is required for all establishments engaged in the recovery,
processing, storage, labeling, packaging, or distribution of any Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT\/Ps), or the screening or testing of a cell or tissue donor.
[A] 4030
[B] 2830
[C] 3356
[D] 1170 [Ans: – [C] 3356<\/p>\n\n\n\n
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RAC Practice Exam 2023-2024 Update
Questions With Complete Solutions
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 [Ans: – D. Summary of Safety and Effectiveness Data
Summary of Safety and Effectiveness Data is not a requirement of a Special 510(k).
Sec. 807.87 Information required in a premarket notification submission.
(j) For submissions claiming substantial equivalence to a device which has been classified into class III
under section 513(b) of the act:
(1) Which was introduced or delivered for introduction into interstate commerce for commercial
distribution before December 1, 1990; and
(2) For which no final regulation requiring premarket approval has been issued under section 515(b)
of the act, a summary of the types of safety and effectiveness problems associated with the type of
devices being compared and a citation to the information upon which the summary is based (class III
summary). The 510(k) submitter shall also certify that a reasonable search of all information known
or otherwise available about the class III device and other similar legally marketed devices has been
conducted (class III certification), as described in 807.94. This information does not refer to
information that already has been submitted to the Food and Drug Administration (FDA) under
section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data
described in the class III summary or citation.
A company is developing a demineralized bone matrix (DBM) product intended as a bone void filler.
The DBM product consists of DBM manufactured from human allograft bone and a polymer gel to
improve handling and containment of the DBM in the bone defect. The DBM product must comply
with the following regulation(s):
A. 21 CFR 210 and 211
B. 21 CFR 820
C. 21 CFR 1271
D. 21 CFR 1271 and 820 [Ans: – D. 21 CFR 1271 and 820<\/p>\n\n\n\n
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Demineralized bone matrix alone (i.e., not combined with another component) is an HCT\/P which
meets the four criteria to be regulated solely under Section 361 of the Public Health Service Act.
FDA, however, has determined the addition of certain components to DBM, such as polymer gels or
calcium phosphates, meets the definition of a device as they are intended to affect the structure or
function of the body by assisting in the filling of bone voids. These DBM products, therefore, are
regulated as devices by CDRH (510(k) clearance required) and as such must comply with 21 CFR 820
Quality System Regulation. In addition, the product also needs to comply with the requirements of
21 CFR 1271 Human Cells, Tissues and Cellular and Tissue-Based Products due to the human tissue
component.
You work for a company that is developing an autologous cellular therapy product. FDA informed
your company that its product will be regulated as an HCT\/P (Human Cells, Tissues and Cellular and
Tissue-Based Product). Based on this information, with which of the following regulatory
requirements will your company need to be compliant when manufacturing the product?
A. 21 CFR 210 \/ 211 (CGMP requirements for pharmaceuticals)
B. 21 CFR 2171 and 21 CFR 820
C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)
D. All Subparts of 21 CFR 1271 [Ans: – C. All Subparts of 21 CFR 1271 except Subpart C (Donor
Eligibility)
As the product is regulated under section 361 of the PHS Act, it is only subject to the requirements in
21 CFR 1271, with the exception of Subpart C, as autologous products are not subject to donor
eligibility requirements.
A drug manufacturer is assembling a clinical evaluation plan for a New Chemical Entity (NCE) to
include in an IND submission. Which of the following NCE studies DOES NOT need to be included by
the manufacturer in the clinical trial registry at www.clinicaltrials.gov?
A. Phase 1 studies
B. Phase 2 studies
C. Phase 3 studies
D. Phase 4 postmarketing studies [Ans: – A. Phase 1 studies
Clinical Trials That Must be Registered at ClinicalTrials.gov\u2014FDAAA, Title VIII, Sec. 801 (“Applicable
Clinical Trials”)<\/p>\n\n\n\n
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\u2014Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of
a product subject to FDA regulation
\u2014Trials of devices: (a) a prospective clinical study of health outcomes comparing an intervention
with a device, subject to FDA regulation, against a control in human subjects, (other than small
feasibility studies), and (b) pediatric postmarket surveillance
The two mechanisms to amend an OTC Monograph are:
A. Time & Extent Application (TEA) or Annual Report
B. Time & Extent Application (TEA) or Citizen Petition
C. Annual Report or Preapproval Supplement
D. Citizen Petition or Preapproval Supplement [Ans: – B. Time & Extent Application (TEA) or Citizen
Petition
Which of the following is NOT required in a Biologics License Application (BLA) but is required in a
New Drug Application (NDA)?
A. FDA form 3397 (user fee cover sheet)
B. Field copy certification
C. Chemistry section
D. Debarment certification [Ans: – B. Field copy certification
Field copy certification only applies to NDA products, whereas all of the others sections are
requirements for both BLAs and NDAs.
Your company would like to submit an IND for the use of a new drug on subjects with a lifethreatening disease for which there are no suitable alternative drugs available. Which type of IND
application would be most suitable for this type of investigation?
A. Treatment IND
B. Emergency Use IND
C. Investigator IND
D. Expanded access IND [Ans: – A. Treatment IND<\/p>\n\n\n\n
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A treatment IND would be most suitable for this application (answer 1). Treatment INDs are issued
as a means of providing eligible subjects with investigational drugs or biologics for the treatment of
serious and life-threatening illnesses for which there are no suitable alternative treatments.
You are assigned the task of obtaining an Orphan Drug Designation (ODD) for a novel investigational
drug for new onset Type I diabetes mellitus. Which of the following is NOT among your points of
consideration for this ODD application?
A. The ODD application must be submitted for review to FDA Office of Orphan Products
Development (OOPD)
B. This investigational drug may qualify for ODD as new onset Type I diabetes mellitus may be a
medically plausible disease subset under the Orphan Drug Act
C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic
Submission Gateway (ESG)
D. The scientific rationale and population prevalence are two areas of the ODD application that are
most critically reviewed by FDA [Ans: – C. The ODD application must be submitted electronically to
the OOPD through the FDA Electronic Submission Gateway (ESG)
Sponsors may send the submission directly to OOPD on physical media with a signed paper cover
letter.
How many days does FDA have to review an Abbreviated 510(k)?
A. 30 days
B. 60 days
C. 90 days
D. 180 days [Ans: – C. 90 days
Because both Special 510(k) and Abbreviated 510(k) are alternate approaches to the Traditional
510(k), with the goal of streamlining evaluation of the application, the Special 510(k) review clock is
30 days. Many people often think the review clock for an Abbreviated 510(k) is also 30 days, but it is
actually 90.
Which federal law made it illegal for physicians being reimbursed by federally funded programs to
prescribe or recommend that the patient use a particular manufacturer’s medical products when the
doctor receives payment from that manufacturer?<\/p>\n\n\n\n
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US RAC Practice Exam Latest Questions
and Answers| Verified Answers
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.
B. 15 calendar days.
C. 30 calendar days.
D. The next quarterly or annual report.
[Ans: – Explanation:
B. There are no 15 day reports included in MDR regulations. 15 Day reports are required b by drug
reporting regulations.
The correct answer is: C
Under the IDE regulation, all of the following must be reported to the sponsor within five working
days
EXCEPT:
A. A deviation from the investigational plan.
B. Withdrawal of IRB approval.
C. An unanticipated adverse device effect.
D. Use of a device without informed consent.
[Ans: – Explanation:
B. Withdrawal of IRB approval is reported within five days.
The correct answer is C.
When design verification testing is being performed by a manufacturer, which element is NOT
included as a potential requirement under device design verification section of the QSR?
A. Identification of the design
B. Software validation<\/p>\n\n\n\n
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C. Identification of test methods used.
D. Name of individuals performing the testing .
[Ans: – Explanation:
B. Software validation is generally included in design validation, not verification (820.30 (g)).
The correct answer is C.
Under the statutory violations, lack of an approved PMA for a PMA device that is not exempt and is
in commercial distribution is considered to be:
A. Adulteration.
B. Improper use.
C. Misbranded.
D. Fraudulent. [Ans: – Explanation:
D. PMA products introduced into commercial distribution without an approval PMA are considered
to be adulterated. FD&C Act 501 (f).
The correct answer is A.
A manufacturer of the following must file an IDE before conducting a human clinical study?
A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance
with its indications in labeling in effect at that time.
B. A device intended solely for veterinary use.
C. A custom device being studied for safety and effectiveness.
D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance
with its indications in labeling in effect at that time. And a device intended solely for veterinary use.
[Ans: – Explanation:
C. While a custom device may be studied in humans without an IDE, if its safety and efficacy are
being studied
in support of commercial marketing, an IDE must be file (21 CFR 812.2(c)(7))
The regulatory affairs professional performs all of the following prior to submitting a PMA to FDA
EXCEPT:
A Preparing criteria for the MDR report.<\/p>\n\n\n\n
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B. Preparing a brief statement of reasons for noncompliance with regulation.
C. Identifying all omissions in PMA content.
D. Reviewing, organizing and checking adequacy of data pertaining to safety and efficacy evaluation.
[Ans: – Explanation:
B. This item is required by 814.20(b)
The correct answer is A
Which of the following sections is required in a PMA?
A. Patent certification information.
B. A copy of quality manual.
C. An economic cost\/benefit assessment.
D. A discussion of benefit and risk considerations. [Ans: – Explanation:
D. See 21 CFR 814.20(b)(3)(vi)
D. A discussion of benefit and risk considerations
Subacute toxicity testing should be performed:
A. In two rodent species.
B. In one rodent and one non-rodent species.
C. For a minimum of two weeks.
D. For a minimum of six months. [Ans: – Explanation:
B. See ICH guideline M3 Maintenance of The ICH Guideline on Non-Clinical Safety Studies for The
Conduct of Human Clinical Trials for Pharmaceuticals.
B. In one rodent and one non-rodent species.
What FDA clearances are required to export a drug approved by FDA?
A. Certificate of Free Sale.
B. Customs Tax Stamps.
C. No clearance required.<\/p>\n\n\n\n
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D. FDA receipt for sample Form-484. [Ans: – Explanation:
C. There are no FDA export requirements for approved products.
C. No clearance required.
Fully quality-assured individual toxicology reports are not required for submission of an initial IND
application. However, finalized and fully quality assured reports should be available to FDA upon
request within what period of the start of the human study?
A 90 days.
B. 120 days.
C. One year.
D. The final report is only required in the submission for the NDA [Ans: – Explanation:
A See FDA “Guidance for Industry Q & A: Content and Format of INDs for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-Derived Products.” OctoBer 2000.
The correct answer is B.
With respect to drug product distribution procedures, a distributor is required to do all of the
following EXCEPT:
A. Establish a system whereby the oldest approved stock of a drug is distributed last.
B. Establish written procedures describing the distribution of drug products.
C. Establish a system whereby the oldest approved stock of a drug is distributed first.
D. Establish a system by which the distribution of each lot of drug product can be readily determined
to facilitate its recall if necessary. [Ans: – Explanation:
A. According to \u00a7211.150, this is not required of a distributor since this way of rotating stock would
potentially allow a drug product to expire in storage while awaiting distribution.
The correct answer is A.
Because of reported dispensing errors due to the similarity of proprietary drug names, one of the
companies involved has decided to quickly and voluntarily notify physicians and others responsible
for providing patient care about the issue via a “Dispensing Error Alert”. In this approach, the
company is NOT required to:<\/p>\n","protected":false},"excerpt":{"rendered":"