ACRP-MDP Medical Device Professional

Under FDA regulations, which class of medical devices requires premarket approval (PMA) because they support or sustain human life and present a potentially unreasonable risk of illness or injury?

• AClass I devices
• BClass II devices
• CClass III devices
• DClass IV devices

A 510(k) premarket notification requires a manufacturer to demonstrate that a new device is:

• ASuperior in performance to all legally marketed devices
• BSubstantially equivalent to a legally marketed predicate device
• CIdentical in design and materials to an existing approved device
• DSafe and effective through randomized controlled clinical trials

What is the primary purpose of an Investigational Device Exemption (IDE)?

• ATo exempt a device from all FDA regulatory requirements permanently
• BTo allow a device to be commercially marketed during the investigation
• CTo permit clinical studies of devices needed to collect safety and effectiveness data for…
• DTo classify a novel device into an existing product code

According to 21 CFR 812, a significant risk (SR) device study requires which of the following before enrollment can begin?

• AFDA approval of the IDE application and IRB approval
• BIRB approval only, without FDA notification
• CFDA approval only, without IRB review
• DSponsor notification to the FDA within 30 days after enrollment begins

Which regulatory pathway was created by the FDA to provide a route to market for novel, low-to-moderate risk devices that lack a predicate?

• APremarket Approval (PMA)
• B510(k) premarket notification
• CDe Novo classification
• DHumanitarian Device Exemption (HDE)

Under ISO 14971, the first step in the risk management process for medical devices is:

• ARisk evaluation against acceptability criteria
• BImplementation of risk control measures
• CHazard identification and risk analysis
• DProduction and post-production monitoring

A clinical investigator discovers that an implantable device malfunctioned during a trial but did not cause patient injury. Under Medical Device Reporting (MDR) requirements, this event must be reported if:

• AThe malfunction could cause or contribute to a death or serious injury if it recurred
• BThe patient experienced at least minor discomfort
• CThe device has been on the market for more than one year
• DThe investigator deems the malfunction clinically insignificant

What does the Unique Device Identification (UDI) system require for medical devices distributed in the United States?

• AA unique serial number assigned by the clinical investigator at the study site
• BA standardized identifier on the device label linked to a database entry in GUDID
• CA barcode containing only the manufacturer's name and lot number
• DRegistration with the World Health Organization before distribution

Under the EU Medical Device Regulation (EU MDR 2017/745), clinical investigations of medical devices must be registered in which database?

• AClinicalTrials.gov
• BGUDID
• CEUDAMED
• DMAUDE

In a medical device clinical trial, the sponsor's primary responsibility for device accountability includes:

• AImplanting the device in study participants
• BMaintaining records of device shipment, receipt, use, return, and disposition
• CDelegating all device tracking to the contract research organization without oversight
• DReporting device accountability only at the end of the study

According to ICH E6 Good Clinical Practice, what is the fundamental principle guiding the ethical conduct of clinical research with medical devices?

• ACommercial viability of the investigational device
• BProtection of the rights, safety, and well-being of trial subjects
• CMinimizing the time to market for new devices
• DEnsuring the sponsor recovers development costs

A non-significant risk (NSR) device study requires which of the following before enrollment begins?

• AFDA approval of an IDE application
• BIRB approval only, with the IRB acting as the IDE authority
• CNeither FDA nor IRB approval
• DA completed PMA submission

During a device clinical trial, the informed consent document must include information about:

• AOnly the benefits of the device, to encourage enrollment
• BThe device's commercial pricing once approved
• CForeseeable risks, expected benefits, and available alternative treatments or devices
• DGuaranteed outcomes from using the investigational device

Which biocompatibility testing standard is most commonly referenced for evaluating medical devices intended for human use?

• AISO 14971
• BISO 10993
• CISO 14155
• DISO 13485

In a device clinical trial, a serious adverse device effect (SADE) must be reported to the sponsor within:

• A30 calendar days
• B7 calendar days
• CAs soon as possible but no later than 24 hours of awareness
• DAt the next scheduled monitoring visit

What distinguishes an unanticipated adverse device effect (UADE) from an anticipated adverse device effect?

• AA UADE is less severe than an anticipated effect
• BA UADE was not identified in nature, severity, or degree of incidence in the investigatio…
• CA UADE occurs only in the control group
• DA UADE is always attributable to user error

Under 21 CFR 812, which party is responsible for selecting qualified investigators and providing them with the information needed to conduct the device investigation properly?

• AThe Institutional Review Board
• BThe clinical research coordinator
• CThe sponsor
• DThe FDA District Director

A clinical research site receives a batch of investigational devices with damaged packaging. The most appropriate immediate action is to:

• AUse the devices as long as the inner sterile barrier appears intact
• BQuarantine the devices, document the damage, and notify the sponsor
• CReturn the devices to the manufacturer without documentation
• DDiscard the devices and order replacements without reporting

Under GCP for device trials, source documents must include:

• AOnly electronic data captured in the EDC system
• BOriginal documents, data, and records that allow reconstruction of the trial
• CSummaries prepared by the monitor after each visit
• DPromotional materials provided by the sponsor

Which of the following best describes the purpose of design controls as required by 21 CFR 820?

• ATo ensure the manufacturing facility passes annual inspections
• BTo provide a systematic framework for developing devices that meet user needs and intende…
• CTo eliminate the need for clinical testing before market clearance
• DTo allow a device to bypass the classification process

When monitoring a device clinical trial, the monitor discovers that informed consent was not obtained from a participant before device implantation. The monitor should:

• AOverlook the finding if the participant did not experience adverse events
• BDocument the finding and immediately notify the sponsor and principal investigator
• CRetroactively sign the consent form on behalf of the participant
• DWait until the final monitoring report to mention the finding

Under FDA regulations, what is the maximum timeframe for a sponsor to submit a report to the FDA for an unanticipated adverse device effect (UADE)?

• A5 working days
• B10 working days
• C15 calendar days
• D30 calendar days

ISO 14155 is the international standard that specifically addresses:

• AQuality management systems for medical device organizations
• BRisk management application to medical devices
• CClinical investigation of medical devices for human subjects
• DBiological evaluation of medical devices

In a pivotal device clinical trial, the primary endpoint is defined as freedom from a composite of death, myocardial infarction, and target vessel revascularization at 12 months. This endpoint is best described as:

• AA surrogate endpoint
• BA composite clinical endpoint
• CA pharmacokinetic endpoint
• DA biomarker endpoint

Which of the following is a key difference between a PMA supplement and a new PMA application?

• AA PMA supplement requires no clinical data
• BA PMA supplement addresses changes to an already-approved device that could affect safety…
• CA PMA supplement is only used when the device changes from Class III to Class II
• DA PMA supplement has a longer review period than a new PMA

During a medical device clinical trial, the IRB's primary role is to:

• ADesign the clinical investigation protocol
• BManufacture and supply the investigational device
• CReview and approve the study to protect the rights, safety, and welfare of human subjects
• DSubmit regulatory filings to the FDA on behalf of the sponsor

A sponsor wants to conduct a first-in-human study of a novel Class III implantable device. Which study type is most appropriate?

• APost-market surveillance study
• BEarly feasibility study under an IDE
• C510(k) bench-testing study
• DRetrospective chart review

Which of the following is NOT required to be included in an IDE application submitted to the FDA?

• AName and address of the sponsor
• BA complete investigational plan describing the study
• CThe device's projected retail price after market approval
• DA description of methods, facilities, and controls used in device manufacturing

A clinical trial site for a device study must maintain essential documents. According to GCP, which of the following is an essential document that must be available at the site during the trial?

• AThe sponsor's marketing plan for the device
• BFinancial disclosure forms of all site staff
• CA signed and dated investigator's brochure or device description
• DThe manufacturer's annual revenue report

In risk management per ISO 14971, the severity of harm and the probability of occurrence of that harm are combined to determine:

• AThe device's regulatory classification
• BThe risk level associated with a hazardous situation
• CThe device's commercial market potential
• DThe number of clinical trial participants needed

When a device manufacturer receives a Medical Device Report (MDR) of a death potentially caused by their device, the report must be submitted to the FDA within:

• A5 calendar days
• B10 working days
• C30 calendar days
• D60 calendar days

In a randomized controlled device trial comparing a new stent to standard medical therapy, what is the most significant challenge related to blinding?

• AInvestigators cannot be trained to use both treatments
• BIt is often impossible to blind participants and investigators to whether a device was im…
• CThe FDA does not allow blinding in device trials
• DBlinding eliminates the need for a control group

The EU MDR requires that medical devices bear a CE mark before being placed on the European market. The CE mark indicates that the device:

• AHas been approved by the U.S. FDA
• BConforms to the applicable EU essential requirements for safety and performance
• CIs covered by the manufacturer's product liability insurance
• DHas been tested by an independent U.S. laboratory

Under 21 CFR 812, a sponsor-investigator for a device clinical trial assumes the regulatory responsibilities of:

• AThe IRB only
• BBoth the sponsor and the investigator
• CThe FDA review division
• DThe contract research organization only

A device clinical trial protocol requires an interim analysis when 50% of participants reach the primary endpoint. The Data Safety Monitoring Board (DSMB) recommends stopping the trial early for efficacy. What is the most appropriate next step?

• AThe sponsor must ignore the DSMB recommendation and continue enrollment
• BThe sponsor evaluates the DSMB recommendation, considers regulatory implications, and mak…
• CThe principal investigator independently stops enrollment at their site only
• DThe IRB terminates the study without consulting the sponsor

Which of the following correctly describes a Humanitarian Device Exemption (HDE)?

• AAn exemption allowing any device to skip clinical testing
• BA marketing authorization for devices intended to benefit patients with conditions affect…
• CA temporary permit allowing off-label use of approved devices
• DAn exemption from all post-market surveillance requirements

During a pre-submission (Q-Sub) meeting with the FDA regarding a planned device clinical trial, the sponsor can expect to discuss:

• AThe final commercial pricing of the device
• BStudy design, endpoints, and the proposed regulatory pathway
• CThe investigator's personal financial investments
• DMarketing strategies for the device post-approval

A participant in a device trial withdraws consent but agrees to allow the use of data collected before withdrawal. Under GCP, the site should:

• ADelete all data collected from the participant
• BContinue follow-up procedures without the participant's knowledge
• CRetain data collected prior to withdrawal and document the participant's wishes regarding…
• DContinue the intervention but stop collecting data

In device clinical trials, the term 'predicate device' is most relevant to which regulatory pathway?

• APremarket Approval (PMA)
• B510(k) premarket notification
• CInvestigational Device Exemption (IDE)
• DHumanitarian Device Exemption (HDE)

Which entity is responsible for conducting the conformity assessment of higher-risk medical devices (Class IIb and III) under the EU MDR?

• AThe device manufacturer's internal quality department
• BA Notified Body designated by an EU member state
• CThe U.S. FDA European liaison office
• DThe World Health Organization

A monitor performing source data verification (SDV) at a device trial site finds a discrepancy between the case report form and the source medical record. The most appropriate action is to:

• AChange the source record to match the CRF
• BIssue a query to the site to resolve the discrepancy and document the finding
• CIgnore the discrepancy if it involves a non-critical data field
• DReport the discrepancy directly to the FDA without informing the site

In the context of medical device clinical trials, what is a 'device deficiency'?

• AA device that exceeds its expected performance specifications
• BAn inadequacy of a medical device with respect to its identity, quality, durability, reli…
• CA device that has been recalled from the commercial market
• DA device that costs more than the budgeted amount

Which of the following is a requirement for labeling of investigational devices under 21 CFR 812?

• AThe label must include the phrase 'FDA Approved'
• BThe label must bear the statement 'CAUTION - Investigational Device. Limited by Federal (…
• CThe label must display the National Drug Code (NDC) number
• DThe label must include the device's anticipated market price

A clinical research coordinator (CRC) at a device trial site discovers that the principal investigator has been enrolling participants who do not meet the study's inclusion criteria. The CRC should:

• AContinue enrolling participants as directed by the PI to avoid conflict
• BDocument the deviations and report them to the sponsor and IRB
• CModify the inclusion criteria in the protocol to accommodate the enrolled participants
• DAdvise the participants to withdraw from the study

Under the EU MDR, a clinical investigation of a medical device that does not bear the CE mark for the intended purpose is classified as:

• AA post-market clinical follow-up (PMCF) study
• BA pre-market clinical investigation requiring competent authority and ethics committee ap…
• CAn observational registry study
• DA retrospective data analysis

The purpose of biocompatibility testing under ISO 10993-1 is to evaluate:

• AOnly the mechanical strength of the device
• BThe biological response to the device based on nature and duration of body contact
• CThe device's electrical safety profile
• DThe device's resistance to environmental degradation during storage