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detailed solutions.
DEVICE RAC EXAM Questions and
detailed solutions.
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 - ANSWER 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) - ANSWER 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 - ANSWER 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 competitor's. When can the company's new suture be marketed?
detailed solutions.
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 - ANSWER A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ANSWER 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 - ANSWER 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. - ANSWER A
detailed solutions.
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls - ANSWER 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 - ANSWER A
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 follow another person's specifications and
do not commercially distribute the devices 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. - ANSWER D
Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
A. An investigator shall report to the sponsor within 5 working days a withdrawal of approval by the IRB.
B. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 10 working days after the use occurs.
C. The sponsor shall notify FDA within 30 working days of the completion or
termination of an investigation for a significant risk device.
D. An investigator shall submit to the sponsor and IRB a report of any unanticipated
adverse device effect within 10 working days after the investigator first learns of the
detailed solutions.
effect. - ANSWER B
When design validation activities are being performed by a manufacturer, which element is NOT included as a requirement under device design validation section of the QSR?
A. Conformance to defined user needs and intended uses
B. Testing of production units under actual or simulated use conditions
C. Software validation
D. Translation of device design into production specifications - ANSWER D
A manufacturer which 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 in support of commercial
marketing
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 intended solely for
veterinary use - ANSWER C
Which one of the following statements is NOT true with respect to both INDs and IDEs for significant-risk products?
A. The investigational product must be manufactured in full compliance with cGMP.
B. Clinical studies 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. - ANSWER A
detailed solutions.
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 III device - ANSWER D
MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT:
A. The establishment must market at least one device in the US and must market a device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends to use and FDA
must agree to the selection. - ANSWER B
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 their 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 - ANSWER A
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
detailed solutions.
C. Detailed knowledge of the manufacturer's operations
D. An internal audit program - ANSWER B
A legally marketed device to which equivalence is drawn in a premarketing submission is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - ANSWER C
A humanitarian device exemption 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. - ANSWER C
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 - ANSWER C
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)
detailed solutions.
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ANSWER D
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. Establishment registration by the initial distributor - ANSWER A
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 - ANSWER B
All of the following are considered General Controls under the FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ANSWER B
detailed solutions.
According to the QSR, 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 - ANSWER C
Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - ANSWER C
For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - ANSWER A
Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?
A) Safe Medical Devices Act of 1990
B) Medical Device User Fee and Modernization Act of 2002
C) Federal Food, Drug, Cosmetic Act
detailed solutions.
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of the trial protocol to FDA for approval - ANSWER D
The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions - ANSWER C
A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA for review?
A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly to FDA
D) Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements - ANSWER A
Under the official definition of a "device", all of the following are considered devices except:
A) X-ray film
B) Sterilizers used for device manufacturing
C) Eyeglass lenses and frames
detailed solutions.
D) In vitro diagnostic kit - ANSWER B
510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except:
A) High Flux Hemodialyzer
B) Blood specimen collection device
C) Piston syringe
D) Cardiopulmonary bypass blood tubing - ANSWER B
The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following:
A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished devices - ANSWER C
The QSR for Class III devices applies to the following except:
A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in the United States
C) Research on investigational devices tested outside of the United States
D) Contract Sterilizers - ANSWER A
The QSR for medical devices (21CFR 820) requires all of the following except:
A) Management to make a commitment to quality
detailed solutions.
A) The Device Master Record (DMR)
B) The documentation from the last phase of the complete Design Control process
C) The test reports that support that the Design Inputs have been met
D) All of the packaging and labeling associated with the finished device
E) A and D above - ANSWER E
According to the QSR, Quality Audits must accomplish the following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above - ANSWER E
According to the QSR, personnel involved in the design, manufacture, distribution, servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their area of responsibility
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not perform their job correctly - ANSWER D
According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
detailed solutions.
D) All of the above - ANSWER D
All of the following are considered General Controls under the FD&C Act except:
A) Establishment Registration
B) Pre-market Approval Application
C) Quality System Regulation
D) Device Listing - ANSWER B
If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - ANSWER A
Pre-market Notification Requirements would apply to a device that is:
A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use - ANSWER A
You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct?
detailed solutions.
The Medical Device User Fee and Modernization Act of 2002 enacted all the following except:
A) User fees for premarket reviews
B) Office of Combination Products
C) Prescription Drug User Fee Act (PDUFA) renewal for five additional years - ANSWER C
What is a major difference between an HDE and a PMA application?
A) Application form and content
B) Labeling requirements
C) Supplemental applications
D) Effectiveness requirements - ANSWER D
The manufacturer of an approved prostate-specific antigen (PSA) test developed a new automated analyzer to perform the total PSA testing. There was no change to the test's indications for use or technology and no new clinical data were required. Only analytical testing was performed to demonstrate that the new analyzer did not alter the performance of the assay. What kind of PMA supplement to the approved PMA will be required for this change?
A) Special PMA Supplements Changes Being Affected
B) 30 day Notice
C) Real Time Supplement
D) 180-Day Supplement - ANSWER D
