DEVICE RAC EXAM QUESTIONS

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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 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

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)

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

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 effect efficacy B. After submission in a periodic report C. After reporting clinical studies in an annual report D. After submission of labeling change

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

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

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

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

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 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

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 manufacture of this product? A. Device QSR regulations B. Drug GMP regulations C. Cosmetic GMP regulations D. No controls required

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

Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act before marketing a device: 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. None of the above

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.

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

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.

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

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

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

The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report

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

The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT: A. Prepare criteria for the MDR report B. Prepare a brief statement of reasons for noncompliance with regulation C. Identify all omissions in PMA content D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation

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

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

Which of the following devices are not subject to requirements for Design Controls? A. Class I devices B. Class II devices C. Class III devices D. None of the above

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.

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

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

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

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

A company is using a clinical research organization (CR0) to develop the protocol and monitor the clinical investigators for the company's clinical trial. The regulatory affairs professional may interact with the CR0 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

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

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 would most likely be assigned? A. Class I B. Class II C. Class III D. Class IV

All Class I medical devices are subject to the following requirements EXCEPT: A. Device Master File (DMF) B. Design History File (DHF) C. Device History Record (DHR) D. Medical Device Reporting (MDR)

All of the following are additional IND submissions to FDA EXCEPT: A. Information amendments B. Protocol deviations C. IND safety reports D. Annual reports

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

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. Provisions to protect the privacy of subjects

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 appropriate department investigate and prepare a deviation report and document all events

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

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

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.

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

The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported. A) Manufacturers B) Distributors C) Initial importers D) User facilities

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

The QSR for medical devices regarding Design Controls require which of the following: A) Documentation of early research of the design B) Design and development plans address how design inputs and requirements are managed C) A product design can be outsourced by a manufacturer so they do not have to maintain the documentation D) Design activities are only required for Class III Investigational devices

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

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, III) is assigned by the FDA B. A Class I recall is for the highest level of risk associated with use of, or exposure to, a defective product C. FDA can mandate a company to recall its marketed product D. A recall is intended to protect the consumer

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

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

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 effect.

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 D) In vitro diagnostic kit

Under whose authority can an imported drug, device or biologic be detained or refused entry into the US? A. U.S Department of Agriculture B. U.S Customs C. FDA D. FBI

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

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 comprising 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

Which of the following conditions may be expected to lead to a field recall action? A) Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of FD&C Act B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection C) Stock Recovery of a device has not left direct control of manufacturer D) Routine servicing

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

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

A GMP audit/inspection against the requirements of 21 CFR 2 10/211 may include auditing of all of the following EXCEPT: A. Complaint files B. Qualifications of consultants C. Pre-clinical laboratory(ies) D. SOPs

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 specification 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

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 post-approval 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

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

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

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.

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

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

A manufacturer of 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

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

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

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

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

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

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

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 which indicates the nature of the alert C. Notify FDA of it's action prior to disseminating the dispensing alert notification D. Include it's name and address in the upper left hand corner of the envelope

Design Control "verification" requires which of the following: A) The product design meets the users needs B) The process produces a product that meets predetermined specifications C) The product design meets specified requirements D) The product design meets the intended use requirements

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

In conformance with GMP, which of the following departments is responsible for approving or rejecting final products? A. Regulatory affairs B. Quarantine and inspection C. Quality control D. Operations

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

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

The QSR for medical devices (21CFR 820) requires all of the following except: A) Management to make a commitment to quality B) A Quality Plan that defines how quality will be met C) Management must review the Quality System at least quarterly D) A Quality representative must be identified and documented

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

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

The following is exempt from the requirements for providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness: A. Broadcast advertising B. Professional labeling C. Reminder advertising D. Direct-to-consumer advertising

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

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

When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA. What is the most practicable first option for a company at this stage? A) File a PMA immediately B) Petition CDRH to downclassify the device C) Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate. D) Submit this product for approval in Europe

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

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

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

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

Which of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before May 28, 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 and B

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? A) Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes. B) Exclude devices from foreign manufacturers from the list being prepared above. C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

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 from the sponsor discusses the issue with the investigator D. Report the protocol deviation to the IRB

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

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

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

Which of the following documentation is NOT included in a Biologics License Application? A. Stability data B. Product labeling C. GLP compliance statements (included in the tox reports) D. Overall quality summary

A 510(k) submission for any Class III device MUST include: A. Clinical results summary B. Hazards analysis evaluation C. Stability evaluation D. Certification and summary

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

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

According to the QSR, Design Inputs are best described by the following: A) The Operator's Manual and instructions on how to use the device B) The Instructions For Use (IFU) of the device C) Marketing claims and features that are required for the device D) The performance requirements that the product must meet

According to the QSR, Document Controls apply to: A) Design History File (DHF) B) Device Master Record (DMR) C) Device History Record (DHR) D) All of the above

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

At completion of review of a 510(k), FDA may take the following actions except: A) Declare device substantially equivalent B) Declare device not substantially equivalent C) State a 510(k) is not required to market the device D) Approve the device for market

At what interval are quality assurance audits conducted for nonclinical studies lasting more than six months? A. One month B. Quarterly C. At completion D. Periodically

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 Inspectional Findings (FD-481) D. List of Observations (FD-483)

FDA defines a label as that which is affixed to the: A. Carton B. Shrink wrapper C. Shipping package D. Immediate container

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

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

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 (sponsor) B. Participation is voluntary C. In order to be eligible, an establishment's most recent inspection must be NAI or VAL D. Establishments are not required to obtain clearance of a 3rd party in advance

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

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 devices

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

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 a PI

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

Under IND/IDE regulations, obligations of a clinical study investigator do NOT include: A. Providing a final study report to the IRB B. Protecting the rights, safety and welfare of study subjects C. Controlling the test materials under investigation during the study D. Keeping all of the unused test material at their facility until the drug/device is approved by the FDA

Under the Medical Device QSR, device design requirements MUST meet the needs of the: A. Manufacturer B. Patient C. User D. Patient and user

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

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

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 D) Medical Device Amendments of 1976

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

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 describe the inspection procedures used by agencies working in collaboration with the FDA

Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA? A) 510(k), Pre-market Notification, Part 807 B) HDE, Humanitarian Device Exemption, Part 814 C) Premarket Approval (PMA), Part 814 D) IDE, Investigational Device Exemptions, Part 812

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

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

Which of the following is exempt from GMP/QS regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers

Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers

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.

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

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

With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial? 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

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. B. You have changed the material composition of the device. C. You have changed the package of the device. D. None of the above.

According to the QSR, Design Outputs contain the following: 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

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

From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development? A) Animal use testing to validate the design of your device B) Bench testing to verify that your design performs as designed C) Biocompatibility/Toxicity testing D) Functional/Safety/Performance testing E) All of the above

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