2023 US RAC Practice Exam Questions With Correct Explanations

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. -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. -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
C. Identification of test methods used.

D. Name of individuals performing the testing . -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. -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. -
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.

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. -
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. -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. -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.

D. FDA receipt for sample Form-484. -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 -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. -Explanation:

A. According to §211.150, 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:

A. Use first class mail and number 10 white envelopes.

B. Use appropriate language on the outside of the mailing envelope that indicates the nature of the
alert.

C. Notity FDA of its action prior to disseminating the dispensing alert notification.

D. Include its name and address in the upper left hand corner of the envelope. -Explanation:

Reference 21CFR §200.5.

The correct answer is C.

A regulatory affairs professional wants to schedule a pre-NDA meeting with the FDA. He or she should:

A. Write a letter to the FDA.

B. Request a Type B meeting as an amendment to the IND.

C. Call the project manager and set up a date over the phone

D. Email the division director with a list of three dates, 30 days into the future. -Explanation:

B. See the CDER/CBER guidance published in February 2000 entitled "Formal Meetings With Sponsors
and Applicants for PDUFA Products".

The correct answer is B.

Which one of the following statements is NOT true with respect to both Investigational New Drug
Applications (INDs) and Investigational Device Exemptions (IDEs) for significant-risk products?

A. The investigational product must be manufactured in full compliance with cGMP.

B. Clinical studies must be 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
excIusion or an environmental assessment. -Explanation:

A. Devices under approved IDEs are exempt from cGMP regulations except for design control
requirements; investigational new drugs must be compliant with cGMP for finished pharmaceuticals
(21CFR 211).

The correct answer is A.

When the proprietary name or designation is used in promotion, the following is TRUE:

A. The proprietary name or designation can, in certain instances, be used without the accompaniment of
the established name.

B. The established name shall be printed in letters that are at least half as large as the letters comprising
the proprietary name or designation with which it is joined.
C. The established name shall be printed in letters that are at least 1/4 as large as the letters
compromising the proprietary name or designation.

D. The proprietary name or designation must be printed in letters at least twice as large as the
established name. -The established name must always accompany the proprietary name and be placed
in direct conjunction with it.

The correct answer is B.

A regulatory affairs professional is developing SOPs for a firm to cover compliance with drug GMPs. The
firm's SOPs should require out-of-specification (OOS) test results to be completed within:

A. A timely manner.

B. 20 days.

C. 30 days.

D. 45 days. -Explanation:

A. 21 CFR 211.192 require an investigation, but do not specify a time frame. October 2006 GMP
guidance states that investigation of out-of-specification test results should be timely.

The correct answer is A.

Which information MUST be included in an IND?

A. A list of all components used in the manufacture of the investigational drug product.

B. A statement of compliance with applicable GMPs.

C. Statistical methods to be used in the analysis of phase II and III clinical trials.

D. Results of accelerated stability studies on three lots of the investigational drug product. -Explanation:

See 21 CFR 312.23(a)(6)(iii).

The correct answer is A

Which of the following documentation is NOT included in a Biologics License Application?

A. Stability data.

B. Product labeling.

C. GLP compliance statement(s).

D. Overall quality summary. -Explanation:

See 21 CFR 601.2.

The correct answer is D.

Under IND/IDE regulations, obligations of a clinical study investigator do NOT include:

A. Providing a final study report to the I RB.

B. Protecting the rights, safety and welfare of study subjects.

C. Controlling the drug under investigation.

D. Returning unused supplies of the drug to the sponsor. -Explanation:

A. 21 CFR 312.64- The investigator is not obligated to submit reports to the IRB. Investigators are

responsible for submitting reports to the sponsor (i.e. -progress reports, safety reports, a final report).

THe correct answer is A.

To be legally effective, a witness must observe the informed consent process at which of the following

times?

A. When the study subject is a minor.

B. When the elements of informed consent are presented orally

C. When the consent is obtained from the subject's legal representative.

D. When the elements of informed consent are written in a foreign language. -Explanation:

B. FDA regulations require a witness to an oral presentation of elements of informed consent to the
subject or the subject's legally authorized representation. 21 CFR 50.27(b)(2).

The correct answer is B.

FDA will do a for-cause inspection of an investigator if the investigator:

A. Conducts a number of pivotal NDA studies.

B. Is only participating in a small number of studies.

C. Appears to have an excessive number of study projects.

D. Consistently reports results different from other investigators. -The correct answer is D.

Which of the following federal laws includes information about ANDA submissions?

A. Antibiotic Amendments of 1945.

B. Durham-Humphrey Amendment of 1951.

C. Drug Amendments of 1962.

D. Drug Price Competition and Patent Term Restoration Act of 1984. -Explanation:

D. This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions of
approved drugs whose patents had expired.

The correct answer is D.

A company's supplier of the active drug substance for the company's OTC drug product informs the
company that the supplier will be moving their production of the drug substance from the current plant
to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing
processes will remain the same and the specifications will not change. The company intends to qualify
the change suitably. How should the company report the change to FDA?
A. The change only needs to be reported in an annual report because the company will qualify the
change and the supplier said the process and specifications won't change.

B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval
supplement) because it is a change to the drug substance manufacturing location.

C. The change does not have to be reported because it is an OTC drug.

D. Not enough information. -Explanation:

B. It is unclear from this question if the OTC drug product is an OTC monograph product for which there
would be no FDA administrative file to report the change to, or if this is an NDA-OTC drug product
(versus an NDA-Rx drug product). For an NDA-OTC drug product, the company would have an approved
NDA file where they could send a supplement for review.

The correct answer is D.

All of the following are additional IND submissions to FDA EXCEPT:

A. Information amendments.

B. Protocol deviations.

C. IND safety reports.

D. Annual reports. -Explanation:

B. Protocol deviations are departures from the specific procedure as described in the protocol or
protocol amendment without prior IRB approval. They need to be reported to the sponsor and are
reported to the IRB, per their individual guidelines.

The correct answer is B.

A minimum of 10 tablets is required to perform all tests for product release. To meet GMP
requirements, reserve samples must be at least:

A. 10 tablets.

B. 20 tablets.
C. 30 tablets.

D. 100 tablets. -Explanation:

The reserve sample consists of at least twice the quantity necessary for each required test. 21 CFR
211.170(a).

The correct answer is B.

When assembling an NDA, all of the following are required EXCEPT:

A. Proposed labeling.

B. Nonclinical toxicology studies.

C. Bioequivalence studies.

D. Manufacturing information. -Explanation:

Bioequivalence data is required in an ANDA, not a NDA, see 21 CFR 314.94(7).

The correct answer is C.

A company has found a way to produce its drug product more economically; however, the current
manufacturing process would have to be changed substantially. What would be the most appropriate
postapproval vehicle for this potential action?

A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0).

B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30)

C. Prior approval supplement.

D. Annual report. -Explanation:

Changes made under this designation are also considered to be moderate, representing a moderate
potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug
product. See FDA's "Guidance for Industry Changes to an Approved NDA or ANDA. See also 21CFR
§314.70(c).
The correct answer is C.

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs
practitioner should submit:

A. The list of all active ingredients, antimicrobial preservatives and antioxidants, with their
pharmaceutical grades and the names of the suppliers.

B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial preservatives
and

antioxidants.

C. GMP Certifications from the suppliers of all active ingredients and excipients.

D. The list of all components used in the manufacture of the drug product, regardless of whether they
appear in the drug product. -Explanation:

21 CFR 314.50(d)(1)(ii).

The correct answer is D.

Which of the following is NOT TRUE for a Memorandum of Understanding (MOU)?

A. MOUs clarify the regulatory responsibilities between the FDA and other federal agencies.

B. MOUs delineate roles and authority of the FDA and state governments.

C. New MOUs are announced in the Federal Register.

D. MOUs are binding agreements that describe the inspection procedures used by agencies
collaborating

with the FDA. -Explanation:

21 CFR 20.108 (c) All such agreements* and understandings shall be published in the Federal Register,
except those agreements and memoranda of understanding between FDA and State or local
government agencies that are cooperative work-sharing agreements.
*Agreements.between the Food and Drug Administration and other departments, agencies, and
organizations.

The correct answer is D.

In order to ensure that a facility complies with GMP requirements, all of the following features should
be

evaluated EXCEPT:

A. Air handling system.

B. Animal supply facilities.

C. Lighting.

D. Potable water. -Explanation:

Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR 58.45.

The correct answer is B.

Under whose authority can an imported drug, device or biologic be detained or refused entry into the
US?

A. US Department of Agriculture.

B. US Customs.

C. FDA.

D. FBI. -Explanation:

B. US Customs is the only US agency that has been granted authority to detain or refuse entry of
imported

products.

The correct answer is B.

Which of the following is NOT true of an Advisory Committee?

A. Advisory Committee meetings can include an oral presentation from a patient advocacy group.

B. Advisory Committee members are selected without regard to race, ethnicity, sex, age or religion.

C. Advisory Committees provide advice to FDA on safety and effectiveness of drugs.

D. Advisory Committees recommend whether a drug should be approved and do not provide advice on
product labeling or clinical trial design. -Explanation:

This is the purpose of the Advisory Committee. 21 CFR 14.160(a).

The correct answer is D.

An IRB will NOT review:

A. Risks and benefits of the proposed research.

B. Risks and benefits of alternative therapies.

C. Prospective informed consent document.

D. revisions to protect the privacy of subjects. -Explanation:

B. FDA regulations do not require an IRB to assess the risks or benefits of alternatives.

The correct answer is B.

The Freedom of Information Act allows a manufacturer to:

A. Make claims about a product already commercially available.

B. Obtain QC methods on a competitor's product.

C. Obtain the Drug/Device Master File of a competitor's product.

D. Obtain public documents on another manufacturer's product. -Explanation:

D. Public documents on another company's product are available through a written quest to the FOIA
office.

The correct answer is D.

At what interval are quality assurance audits conducted for nonclinical studies lasting more than six

months?

A. Once a month.

B. Quarterly.

C. At completion.

D. Periodically. -Explanation:

D. Periodic inspections by the quality assurance unit is required as appropriate for the study. 21 CFR
58.35

(b)(3).

The correct answer is D.

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as:

A. Product recall.

B. Stock recovery.

C. Market withdrawal.

D. Corrective action. -Explanation:

Product recall applies when a product is considered in violation of the law and the agency can initiate

legal action. 21 CFR 7.3(g).

The correct answer is C.

Due to mechanical failure, a product line has remained in process for five days over the time limit
established in the company's SOPs. Which of the following should be done first?

A. Reject the product since the time limit has been exceeded.

B. Proceed with processing and quarantine the product.

C. Complete the manufacturing process and ship the product.

D. Have the Regulatory Affairs department investigate and prepare a deviation report and document all
events. -Explanation:

B. This would give the company time to conduct an investigation. 21 CFR 211.111 and 21 CFR 820.90,

Nonconforming product, describes the requirements for control of non conforming product,
nonconformity

review and disposition, etc. for medical devices.

The correct answer is B.

A 510(k) submission for any Class Ill device MUST include:

A. Clinical results summary.

B. Risk analysis.

C. Stability evaluation,

D. Certification and summary. -Explanation:

Although the design control regulations applicable to all Class III devices require risk analysis as part of

design validation (21 CFR 820.30(g)), the risk analysis is not required to be included in Class Ill 510(k)s.

The correct answer is D.

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 competitor's. 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.

D. After submission of labeling change. -Explanation:

A. This requires a new 510(k) since significant change in product instructions might affect efficacy.

Explanation:

A. A new intended use requires a 51 O(k) clearance.

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the:

A. Market comparator device.

B. Placebo device

C. Predicate device.

D. Substantially equivalent device. -The correct answer is C.

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these
inspections EXCEPT:

A. You need to market at least one device in the United States.

B. Participation is mandatory.

C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI

D. Establishments are not required to obtain clearance of a 3rd party in advance. -Explanation:

D. Requirement per section 704(g)(6)(A)(ii) of MDUFMA.

The correct answer is B.

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT:

A. Establishment registration.

B. Premarket approval application.

C. Medical device reporting.

D. Listing of the device. -Explanation:

PMA is not a general control

The correct answer is B.

Which of the following manufacturers must register their manufacturing facility with FDA?

A Component manufacturers who sell only to the device manufacturer using their components.

B. Domestic (US) contract manufacturers who do not directly distribute the final product to the market.

C. Domestic manufacturer of device being investigated under an IDE.

D. Foreign manufacturers shipping devices into the US for sale in the US. -Explanation:

D. All foreign manufacturers making devices distributed in the US must register with FDA.

The correct answer is C.

Premarket Notification is required of manufacturers when introducing:

A New label size.

B. New Class II devices.

C. A change in product name.

D. Additional manufacturing sites. -Explanation:

C. This is not considered a significant change in the device.

The correct answer is B.

The initial importer of a medical device MUST:

A. Register and submit device list to FDA.

B. Maintain quality assurance files.

C. Share responsibility for submittals with other distributors.

D. Report device malfunctions in an annual report. -Explanation:

A. Distributors must list all initially imported devices with the FDA and establish themselves as device

importers. 21 CFR 807.20(c).

The difference between advertising and professional labeling is that:

A. Advertising can be directed to only consumers and professional labeling can be directed to only
professionals.

B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief

summary.

C. Advertising can be directed to either consumers or professionals while professional labeling can be
directed to only consumers.

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied
by Pl. -Explanation:

D. This statement is true.

The correct answer is D.

All of the following are required for compliance to 21 CFR Part 11 (electronic records and electronic
signatures) EXCEPT:
A. Manually generated, time-stamped 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, reliability, consistent intended performance and the ability
to discern invalid or altered records.

C. Authority checks to ensure that only authorized individuals can use the system, electronically sign a
record, access the operation or computer system input or output device, alter a record or perform the
operation at hand.

D. Establishment of, and adherence to, written policies that hold individuals accountable and
responsible for actions initiated under their electronic signatures, in order to deter record and signature
falsification. -Explanation:

A. Time-stamped audit trails must be secure, computer-generated records that independently record
the date and time of operator entries and actions that create, modify, or delete electronic records.
Manually generated records are NOT acceptable. 21 CFR 11.10 (e).

THe correct answer is A.

A company has been given a product from its British subsidiary to market for the first time in the US. The
product is marketed in the EU. A project team gathered by the regulatory professional to review the
information available for regulatory submission to FDA should:

A. Focus on labeling and marketing since mutual recognition does not require complete technical
review.

B. Include production, marketing, QA and clinical research for a thorough review.

C. Summarize financial data and distribution data which are normally required to be submitted to FDA.

D. Not be necessary if a Common Technical Document has been prepared by the subsidiary. -
Explanation:

D. It is the sponsor's responsibility to assure the accuracy of the submission.

The correct answer is B.

A marketing department plans to launch a series of educational speaker's programs for one of the
company's drug/biologic products. Which of the following statements is a regulation that applies to
promotional activities?

A. Adequate and well-controlled studies are required to substantiate all conclusions presented.

B. The company may suggest speakers or content for the presentations.

C. An independent third-party organization must manage the seminar series.

D. All speakers must disclose any financial relationships with the sponsoring company. -Explanation:

A. This is interpreted as a promotional activity and subject to advertising regulations. There is also a
variety

of FDA guidance documents addressing these activities. CFR 02.1 (e)(6)(ii).

The correct answer is A.

The following is exempt from the requirements for providing a true statement of information in brief
summary relating to side effects, contrairldications and effectiveness:

A. Broadcast advertising.

B. Professional labeling.

C. Reminder advertising.

D. Direct-to-consumer advertising. -Explanation:

C. This is not required for this type advertisement. Refer to 21 CFR 202(e)(2) for explanation.

The correct answer is C.

A company has received a 10-page FDA-483. The regulatory affairs professional's supervisor has
prepared a detailed response assuring the FDA district office that corrective action has been taken for
each observation. Which of the following should be done?
A. Re-audit the company's corrective actions before the letter is sent.

B. Re-audit the company's corrective actions within three months because FDA usually conducts
reinspections within six months.

C. Re-audit the company's corrective actions during the next scheduled audit.

D. Re-audit the company's corrective actions immediately after the letter is sent. -Explanation:

A. The letter from the supervisor states the corrective actions have already taken place. The firm may be
subject to inspection at any time; therefore, these corrections should be reviewed. Title 18 of the US
Code makes submitting false information to the government a criminal offense.

The protocol for a non-clinical laboratory study must contain all of the following EXCEPT

A. The species, strain and age of the test system.

B. The dated signature of the sponsor representative.

C. A description of the methods for the control of bias.

D. The type and frequency of tests and measurements. -Explanation:

C. This is required. 21 CFR 58.120(a)(6).

The correct answer is B.

While examining complaint files, a quality assurance practitioner notices that there are several
complaints of microbial contamination of one product lot. To determine the possible source of the
problem, what records should be examined first?

A. Sterilization and water system validations.

B. Environmental monitoring.

C. Raw material/supplier records.

D. Batch or product history record. -Explanation:

D. Batch records or device history records should be examined first to look for production deviations
during the manufacture of that lot.
The correct answer is D.

FDA may perform a pre-approval inspection of an applicant's manufacturing facility before approving an
application. The filing of which of the following submissions does NOT automatically activate the
consideration of a pre-approval inspection?

A. New Drug Application.

B. Abbreviated New Drug Application.

C. Pre-Market Approval Application.

D. Drug/Device Master File. -Explanation:

D. FDA regulations do not require pre-approval inspections of Drug/Device Master Files.

The correct answer is D.

During a review of an internal audit, the auditor discovers a product being manufactured consisting of a

battery-operated toothbrush impregnated with non-fluoridated toothpaste. There are no controls for
the

manufacture of the finished product. Compliance with which of the following is required for the
manufacturer

of this product?

A. Device QSR regulations.

B. Drug GMP regulations.

C. Cosmetic GMP regulations.

D. No controls required. -Explanation:

D. The battery-operated toothbrush is a device and covered by GMPs. See 21 CFR 872.6865, 860.3(C)(1).

The correct answer is A.

In the development of a revised manufacturing procedure, which of the following is a critical step in
ensuring that the product manufactured would not be adversely affected by this change?

A. Procedure qualification.

B. Product verification and/or process validation.

C. Quality control.

D. Conformance inspection. -Explanation:

B. This ensures that the product has not been adversely affected.

The correct answer is B.

FDA defines a label as that which is affixed to the:

A. Carton.

B. Shrink wrapper.

C. Shipping package.

D. Immediate container. -Explanation:

D. The term "label" has a narrow meaning limited to the display of written, printed or graphic matter
upon

the immediate container of an article. 21 CFR 201 (Subpart A).

The correct answer is D.

During an audit of a manufacturing site, the FDA inspector learns that complaints from the field are not

being adequately documented. At the closing meeting, the FDA inspector presents:

A. Establishment Inspection Report (EIR).

B. Establishment Registration Report (ERR).

C. Summary of lnspectional Findings (FD 481).

D. List of Observations (FD-483). -Explanation:

D. Inspector shares this form with the firm before leaving the site.

The correct answer is D.

Which is true about electronic submissions?

A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic.

B. The FDA does not have a preferred format/file structure for e-submissions.

C. Only NDAs may be submitted electronically.

D. All FDA divisions accept electronic submissions. -Explanation:

A. According to the guidance "Guidance for Industry: Providing Regulatory Submissions in Electronic

Format-Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications",

first published in October 2005 and revised in April 2006, Section E, "Once you begin to submit a specific

application in electronic format based on this guidance, subsequent submissions to the application,

including amendments and supplements, should include eCTD backbone files."

The correct answer is A.

Which division would have a primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?

A. CDER.

B. CBER.

C. CDRH.

D. OCP -Explanation:
D. the Office of Combination Products, created as part of MPUFMA in 2002, has broad regulatory

responsibilities covering the regulatory life cycle of combination products but the primary responsibility
for

oversight and regulation of these products is still in the hands of the center to which they are assigned

(CDER, CBER or CDRH).

The correct answer is C.

Which of the following is NOT TRUE regarding the recall of a product from the market that is deemed to
be in violation of FDA laws:

A The classification for a recall (I, II, Ill) is assigned by the FDA

B. A Class I recall is for the highest level of risk associated with the product.

C. FDA can mandate a company to recall its marketed product.

D. A recall is intended to protect the consumer. -Explanation:

B. A Class I recall has the highest risk classification associated with the recall itself. See 21 CFR 7.3(m)

The correct answer is B.

Which of the following is NOT true regarding 21 CFR Part 11?

A. Applies to records in electronic form that are created, modified, maintained and archived for
regulatory reasons.

B. Applies to all electronic records submitted to FDA under the FD&C Act.

C. Part 11 will be interpreted narrowly.

D. Predicate rule record and record keeping requirements are optional. -Explanation:

D. Predicate rule record and record-keeping requirements are enforced.

The correct answer is D.

The Quality System Regulation 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. -Explanation:

Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to
determine that quality system activities comply with quality system procedures that these procedures
are implemented effectively and that procedures are suitable to achieve quality system objectives.

The correct answer is B.

Which of the following is exempt from GMP/QS regulations?

A. Remanufacturers.

B. Custom device manufacturers.

C. Repackagers.

D. Component manufacturers. -Explanation:

D. Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

The correct answer is D.

Under the Medical Device Quality System Regulation, device design requirements MUST meet the needs
of the:

A. Manufacturer.

B. Patient.

C. User.

D. Patient and user. -Explanation:

D. QSR requires design input as defined in 21 CFR 820. 30 (c) meet the needs of both the patient and
user.

The correct answer is D.

A humanitarian device exemption (HDE) differs from a traditional PMA in that:

A. It does not require compliance with QSR.

B. Non-clinical data are not required.

C. Effectiveness data are not required.

D. Device characteristics are not required. -Explanation:

C. See Section 520 ((m) of the FD&C and 21 CFR 814.104(b)(4).

The correct answer is C.

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. Complaint files.

D. Design history file. -Explanation:

A. This contains the dates of manufactured, the quantity manufactured, the quantity released for
distribution, control numbers used and the acceptance records which demonstrate the device is
manufactured in accordance with the DMR. 21 CFR 820.184.

The correct answer is A.

To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to

be:

A. In a building separated from other manufacturing buildings.

B. In plants that are inspected quarterly.

C. In a facility with a separated air handling system from those used for other drug products for human
use.

D. Under laminar flow protection that is validated periodically. -Explanation:

C. GMP requires dedicated facilities for penicillin manufacture with separate air handling system from
other drug products used for human use. 21 CFR 211.42(d), 211.46(d).

Which of the following is NOT TRUE regarding post-approval pharmacovigilance for a drug?

A. It is intended to detect all medically important adverse effects and uncommon safety risks in the "real

world" of clinical practice.

B. Health professionals report all adverse drug reactions associated with the use of a marketed drug.

C. Adverse effects from products in the same pharmacologic class as the marketed drug must be

considered along with those for the marketed drug.

D. Serious and unexpected adverse drug reactions in patients treated with the product outside the
United

States need to be reported within 15 days after initial notification. -Explanation:

C. A safety signal associated with products in the same pharmacologic class is also part of post-approval

pharmacovigilance.
The correct answer is B.

A personal deodorant manufacturer is required to do all of the following EXCEPT:

A Comply with GMP.

B. State the place of business on the label.

C. List the quantity of contents on the label.

D. Comply with export regulations when exporting product. -Explanation:

This is required by the regulations. Fair Packaging and Labeling Act, Section 4(a).

The correct answer is A.

Which type of protocol is NOT eligible for a Special Protocol Assessment under the PDUFA?

A. Animal carcinogenicity study protocol.

B. Phase 3 clinical study protocol, which its data is the primary basis for an efficacy claim.

C. Final product stability study protocol.

D. Bioequivalence study protocol. -Explanation:

SPAs provided in FDA's Guidance for Industry Special Protocol Assessment (May 2002), Phase Ill studies

protocols are part of the PDUFA goals for special protocol assessment.

The correct answer is D.

The marketing department has designed a journal advertisement that mentions leadership in a
particular therapeutic area and includes only the name of the company's approved prescription drug
products. Which of the following should be included in the advertisement to be in compliance with
regulations?
A. Full prescribing information.

B. A brief summary of the prescribing information.

C. All the available names of the drug product and the established name of each of the active
ingredients in the drug product.

D. A complete listing of adverse events. -Explanation:

All advertisements for any prescription drug as regulated under 21 CFR 202.1(e)(1) require providing a

statement of information in brief summary relating to side effects, contraindications and effectiveness.

The correct answer is C.

A GMP audit/inspection against the requirements of 21 CFR 210/211 may include auditing of all of the

following EXCEPT:

A. Complaint files.

B. Qualifications of consultants.

C. Pre-clinicallaboratory(ies).

D. SOPs -Explanation:

C. Pre-clinical laboratories are audited under the provisions of Good Laboratory Practices, 21 CFR 58.

The correct answer is C.

Which of the following is true about DMFs?

A. DMFs are not reviewed until referenced by a marketing application.

B. DMFs do not require annual updates.

C. The only types of DMFs recognized by the FDA are Type I, Type II and Type III

D. A sponsor does not need written permission to reference a DMF. -Explanation:

A See 21 CFR 314.420(a) and the COER guidance entitled "Guidance for Drug Master Files" published

September 1989.
The correct answer is A.

A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from
the FDA, what is the earliest that clinical studies can be initiated?

A The sponsor must wait for FDA approvaL

B. Upon IRB approval from any study center.

C. 30 days from receipt by FDA

D. 90 days from receipt by FDA -Explanation:

C. The IDE/IND goes into effect 30 days after receipt by FDA, unless FDA notifies the sponsor that the
IDE/IND is on clinical hold. 21 CFR 812.30 (a)(1), 312.40(b)(1).

The correct answer is C.

A clinical study sponsor's representative conducts periodic monitoring site visits for all of the following

purposes EXCEPT to:

A Review raw data.

B. Ensure compliance with the protocol

C. Review the protocol with the investigator.

D. Ensure the adequacy of the IRB and its procedures. -Explanation:

D. An institution conducting clinical investigations is responsible for the integrity of the IRB and is held

accountable. There is a degree of confidentiality that may not be breached by a study monitor. The

investigator, through the signed 1572 form, assures the sponsor of IRB review. 21..CFR 812.100,
812.110;

21 CFR 312.66,21 CFR 812.150(a)(2), 812.140(a)(1).

The correct answer is D.

Which of the following is NOT a responsibility of clinical investigators?

A. Submitting notices to the IRB of deviations from the investigational plan.

B. Maintaining records of receipt, use and disposition of investigational product. ,

C. Reporting to the sponsor withdrawal of IRB approval.

D. Submitting unanticipated adverse event reports to FDA. -Explanation:

Any changes in investigational plans must have IRB approval and is the investigator's responsibility.

The correct answer is D.

All of the following are requirements of an IRB EXCEPT that it:

A. Is composed of at least five members.

B. Includes at least one non-scientific member.

C. Obtains informed consent from all subjects.

D. Represents the cultural mix of the community. -Explanation:

The regulations require each IRB to have a diversity of members, including consideration of race, gender

and cultural backgrounds, which will have sensitivity to community attitudes. 21 CFR 56.1 07(a).

The correct answer is C .

During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical
investigation without obtaining informed consent from the subject. Which of the following should the
regulatory affairs professional do?
A. Predate the informed consent with a memo to the site file.

B. Contact the patient to obtain the informed consent immediately.

C. Ensure that the study director for the sponsor discusses the issue with the investigator.

D. Report the protocol deviation to the IRB. -Explanation:

D. This is the responsibility of the investigator [per 812.150(a)(5)].

The correct answer is C.

Which of the following does NOT discuss the protection of human subjects?

A. Nuremberg Code.

B. Declaration of Helsinki.

C. Drug Amendment of 1962.

D. Food Drug and Cosmetic Act of 1938. -Explanation:

Nuremberg Code of Ethics in Medical Research required a subject's informed consent.

The correct answer is D.

A company is using a clinical research organization (CRO) to develop the protocol and monitor the
clinical investigators for the company's clinical trial. The regulatory affairs professional may interact with
the CRO in which of the following situations?

A. Making presentations to the reviewing IRBs.

B. Making presentations to the reviewing division at FDA.

C. Witnessing the signing of patient consent forms.

D. Arranging for FDA investigators to observe treatment of subjects at clinical sites. -Explanation:

B. The CRO may assist the company in explaining the clinical protocol or data to FDA.
The correct answer is B.

Which of the following changes require FDA approval of NDA supplements before the change is made?

A. Adding an additional test method.

B. Deleting a dye from the drug product.

C. Making changes that comply with USP.

D. Relaxing the limits for a drug substance specification -Explanation:

D. Prior FDA approval is required for a noncompendial relaxation of release specification limits 21 CER

314.70.

The correct answer is D.

According to the drug regulations, the FDA will most likely put an IND study on clinical hold for which of
the following reasons:

A. Human subjects are exposed to a reasonable degree (non-significant) or risk of illness or injury by
participating in the trial.

B. The manufacturer charges a fee for the investigational product.

C. The clinical investigators are qualified by scientific training or experience to conduct the study
described in the investigator's brochure.

D. The sponsor is not pursuing marketing approval with due diligence. -Explanation:

If the risk is reasonable, FDA will probably not put the IND on hold.

The correct answer is D.

In conformance with GMP, which of the following departments is responsible for approving or rejecting
finished pharmaceuticals?
A Regulatory affairs.

B. Quarantine and inspection.

C. Quality control.

D. Operations. -Explanation:

C. QC has the responsibility and authority to approve or reject final products, 21 CFR 211.22.
Establishment of a Quality system is a requirement for QSR, 21 CFR 820.5, 820.20, 820.22, 820.80.
Additional information is available in Medical Device Quality Systems Manual: A Small Entity Compliance
Guide. GTPs also mandate establishment of a Quality Program, 21 CFR 1271.160.

The correct answer is C.

Which of the following is NOT true regarding ANDAs filed under paragraph IV certification?

A They allow companies to seek approval of an ANDA before the expiration date of the patent for the
reference drug.

B. The first company to receive approval of the ANDA has exclusive marketing rights for 180 days

C. Notification of the ANDA submission to the original patent holder is not required at the time of
submission

D. Patent holders have 45 days to file an infringement suit against the filer. -Explanation:

Per the Hatch Waxman Act and 21 CFR 314.94(a)(12)(i)(A)(4).

The correct answer is C.

Which of the following is NOT true for an FDA inspection of a facility that manufactures a small molecule

drug?

A. A notice of inspection (FDA 482 form) is presented by the FDA investigator on arrival at the facility.

B. The credentials of the FDA investigator can be photocopied for filing at the facility.

C. The FDA investigator provides inspectional findings on a FDA 483 form.

D. The FDA investigator provides an FDA 484 form to describe samples taken during the inspection. -
Explanation:

A receipt of samples obtained during the course of inspection must be provided prior to leaving the

premises. Section 704 [21 U.S.C. 374] (c) of the FD&C Act

The correct answer is B.

Distribution records for drug products must reference or contain all of the following EXCEPT:

A Name and address of the consignee.

B. Name and strength of the product and description of the dosage form.

C. Lot or control number and date and quantity shipped.

D. Purchase order number and date ordered. -Explanation:

D. This is not required under 21 CFR 211.196.

The correct answer is D.

The clinical research department has identified a new indication for one of the company's marketed
drugs based on efficacy in preclinical models. The formulation for the drug product and the route of
administration would be different. As the regulatory affairs professional, you should set up a meeting to
discuss the regulatory path forward with which of the following departments in your company?

A. Only the regulatory department is needed to decide the regulatory path forward.

B. Regulatory, clinical and toxicology departments.

C. Regulatory, clinical, toxicology, manufacturing and marketing departments.

D. Regulatory, clinical, toxicology, manufacturing, marketing and shipping and receiving departments. -
Explanation:

C. Input from a number of key departments is needed to decide what GLP toxicology and clinical studies,
manufacturing/formulation activities and resources would be necessary for this project and if pursuing
the

project is feasible from a marketing perspective.

The correct answer is C.

According to the Quality System Regulation, suitable maintenance of equipment is necessary to ensure
that manufacturing specifications are met. All of the following are requirements for the equipment
EXCEPT:

A. A written maintenance schedule is required.

B. Allowable tolerances are posted on or near the equipment.

C. Maintenance must be performed at least annually.

D. Inspections of equipment must be documented. -Explanation:

C. Incorrect. The requirement states that maintenance must be performed on a periodic basis, not "at
least annually."

The correct answer is 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 labeling is revised.

B. The product is recalled.

C. The product is redesigned.

D. A "Dear Doctor" letter is issued. -Explanation:

A. The labeling should provide appropriate information for proper use of the product.

The correct answer is A.

A defective product was released into distribution and has caused patient injuries. The patients were
treated in a local hospital and may suffer further reversible medical consequences as a result of the
defective product. If this product is recalled from the market, which of the following recall classifications
swould most likely be assigned?

A. Class I

B. Class II.

C. Class Ill.

D. Class IV. -The correct answer is 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. Buildings and facilities. -Explanation:

B. This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not by

quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals are

required by 21 CFR 211, Subpart I.

A company wants to modify its device such that there is a major change to the fundamental scientific
technology of the device. The FDA has published a guidance on this technology and special controls have
been established. This change would be best filed as a(n):
A. Special 510(k).

B: Abbreviated 510(k).

C. Traditional 510(k).

D. PMA. -Explanation:

A premarket approval application is not necessary for these types of changes to an existing device.

The correct answer is B.

Inspections of device components received from a supplier may frequently reveal product quality
deficiencies. To avoid these instances, the supplier should first have:

A Expert GMP knowledge.

B. Clear and precise specifications from the manufacturer.

C. Detailed knowledge of the manufacturer's operations.

D. An internal audit program. -Explanation:

B. An agreement outlining the manufacturer's specifications would minimize quality deficiencies. 21 CFR
620.81 (b).

The correct answer is B.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of:

A Class I and II devices.

B. Class I devices only.

C. Class II devices only.

D. Class II and Ill devices. -Explanation:

Class I devices are the least hazardous and are not the primary focus of FDA inspections. Third party

inspections allow FDA to focus on higher-risk inspections.

The correct answer is D.

FDA has sent a warning letter citing mislabeling of a small manufacturer's artificial knee device. The

regulatory affairs professional should first contact the:

A. Compliance Branch in the district.

B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation.

C. Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in CDRH.

D. CDRH Ombudsman. -Explanation:

This is a compliance issue, not a device evaluation issue.

The correct answer is A.

A product storage and handling 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. -Explanation:

D. Procedures to prevent deterioration are required, but environmentally controlled areas are required
only

when environmental conditions could reasonably be expected to have an adverse effect on quality. 21
CFR

820.150(a)
The correct answer is C.

A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for
the lack of:

A. Establishment registration by the foreign manufacturer.

B. Medical device listing by the foreign manufacturer.

C. Substantially equivalent letter from FDA.

D. Medical device listing by the initial importer. -Explanation:

D. Although 21 CFR 807.20(a)(5) implies that initial importers are required to list the products, this is not
required/enforced at this time per CDRH Device Advice.

The correct answer is D.

Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act before
marketing a device that requires such notification:

A. Makes the product misbranded under Section 502 of the Act.

B. Introduces an unapproved product into interstate commerce.

C. Causes the product to be mislabeled.

D. Will initiate Compliance Office action to require submission of a PMA. -Explanation:

A. The product is considered to be misbranded if the product is not cleared through the 510(k) process.
FD&C Act, Section 502(o).

Note: A product is considered adulterated if the product requires an approved PMA but does not have
one.
The correct anwer is A.

Which of the following devices are not subject to requirements for Design Controls?

A. Class I devices exempted by regulation.

B. Class II devices that have been down classified from Class Ill.

C. Class Ill devices.

D. Devices automated with computer software. -Explanation:

A. While most Class I devices are not subject to design controls, Class I devices listed in 820.30(a)(2) are

required to be under design controls.

The correct answer is A.