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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?

Class I devices

Class II devices

Class III devices

Class IV devices

to track

2026 Statistics

Key Facts: ACRP-MDP Exam

Exam Questions (10 unscored)

ACRP MDP exam page

90 min

Exam Time

ACRP MDP exam page

600

Passing Score (200-800 scale)

ACRP Certification Handbook

$250-$300

Exam Fee (member/non-member)

ACRP MDP exam page (2026)

2 years

Certification Renewal Period

ACRP Maintenance of Certification Handbook

July 2026

ICH E6(R3) Effective Date

ACRP MDP exam page

ACRP lists the MDP specialty exam at 60 multiple-choice questions (10 unscored pre-test items) in 90 minutes, with a scaled passing score of 600 on a 200-800 scale. Current exam fees are $250 for ACRP members and $300 for non-members with no separate application fee. Beginning July 15, 2026, ICH E6(R3) will replace E6(R2) across all ACRP examinations. Candidates must already hold an active ACRP certification (CCRC, CPI, ACRP-CP, or CCRA) to sit for this specialty exam.

Sample ACRP-MDP Practice Questions

Try these sample questions to test your ACRP-MDP exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Under 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?

A.Class I devices

B.Class II devices

C.Class III devices

D.Class IV devices

Explanation: Class III devices are the highest-risk category under the FDA classification system. They typically require PMA because they support or sustain human life and present a potentially unreasonable risk. Examples include implantable pacemakers and heart valves. The ACRP-MDP exam expects familiarity with device classification and the regulatory pathways associated with each class.

2A 510(k) premarket notification requires a manufacturer to demonstrate that a new device is:

A.Superior in performance to all legally marketed devices

B.Substantially equivalent to a legally marketed predicate device

C.Identical in design and materials to an existing approved device

D.Safe and effective through randomized controlled clinical trials

Explanation: The 510(k) pathway requires demonstrating substantial equivalence to a legally marketed predicate device with respect to intended use, design, and technological characteristics. This does not necessarily require clinical trials. The 510(k) is the most commonly used premarket submission for Class II devices.

3What is the primary purpose of an Investigational Device Exemption (IDE)?

A.To exempt a device from all FDA regulatory requirements permanently

B.To allow a device to be commercially marketed during the investigation

C.To permit clinical studies of devices needed to collect safety and effectiveness data for PMA or 510(k)

D.To classify a novel device into an existing product code

Explanation: An IDE allows investigational devices to be used in clinical studies to collect the safety and effectiveness data required for PMA applications or 510(k) submissions. The IDE provides an exemption from certain regulatory requirements that would otherwise apply to marketed devices, but it does not exempt the device from all regulations or allow commercial distribution.

4According to 21 CFR 812, a significant risk (SR) device study requires which of the following before enrollment can begin?

A.FDA approval of the IDE application and IRB approval

B.IRB approval only, without FDA notification

C.FDA approval only, without IRB review

D.Sponsor notification to the FDA within 30 days after enrollment begins

Explanation: For significant risk device studies, 21 CFR 812 requires both FDA approval of the IDE application and IRB approval before the study can begin enrolling participants. This dual-approval requirement ensures adequate oversight of higher-risk investigations. Non-significant risk studies, by contrast, require only IRB approval.

5Which regulatory pathway was created by the FDA to provide a route to market for novel, low-to-moderate risk devices that lack a predicate?

A.Premarket Approval (PMA)

B.510(k) premarket notification

C.De Novo classification

D.Humanitarian Device Exemption (HDE)

Explanation: The De Novo classification pathway allows novel devices that are low-to-moderate risk but have no predicate device to be classified into Class I or Class II. Once a De Novo device is authorized, it can serve as a predicate for future 510(k) submissions. This pathway fills the gap between 510(k) and PMA.

6Under ISO 14971, the first step in the risk management process for medical devices is:

A.Risk evaluation against acceptability criteria

B.Implementation of risk control measures

C.Hazard identification and risk analysis

D.Production and post-production monitoring

Explanation: ISO 14971 outlines a systematic risk management process that begins with hazard identification and risk analysis. This involves identifying known and foreseeable hazards, estimating risks, and then evaluating those risks against predetermined acceptability criteria before implementing controls. Understanding this sequence is fundamental for the ACRP-MDP exam.

7A 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:

A.The malfunction could cause or contribute to a death or serious injury if it recurred

B.The patient experienced at least minor discomfort

C.The device has been on the market for more than one year

D.The investigator deems the malfunction clinically insignificant

Explanation: Under MDR regulations (21 CFR 803), device malfunctions must be reported if the malfunction would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Actual injury is not required for reporting; the potential for harm upon recurrence triggers the obligation.

8What does the Unique Device Identification (UDI) system require for medical devices distributed in the United States?

A.A unique serial number assigned by the clinical investigator at the study site

B.A standardized identifier on the device label linked to a database entry in GUDID

C.A barcode containing only the manufacturer's name and lot number

D.Registration with the World Health Organization before distribution

Explanation: The UDI system requires a standardized device identifier on the device label (or the device itself) that is linked to a publicly searchable entry in the Global Unique Device Identification Database (GUDID). The UDI includes a device identifier (DI) for the specific device version/model and a production identifier (PI) for lot, serial number, or expiration date.

9Under the EU Medical Device Regulation (EU MDR 2017/745), clinical investigations of medical devices must be registered in which database?

A.ClinicalTrials.gov

B.GUDID

C.EUDAMED

D.MAUDE

Explanation: The European Database on Medical Devices (EUDAMED) is the EU MDR's designated electronic system for registration and tracking of clinical investigations, device information, certificates, and vigilance reporting. While sponsors may also register on ClinicalTrials.gov, EUDAMED registration is the EU-specific regulatory requirement under MDR 2017/745.

10In a medical device clinical trial, the sponsor's primary responsibility for device accountability includes:

A.Implanting the device in study participants

B.Maintaining records of device shipment, receipt, use, return, and disposition

C.Delegating all device tracking to the contract research organization without oversight

D.Reporting device accountability only at the end of the study

Explanation: The sponsor must maintain comprehensive records of investigational device accountability, including shipment, receipt, use, return, and disposition at each site. This ensures traceability throughout the trial and is a key GCP requirement for device studies. Accountability must be ongoing throughout the study, not just at closeout.

About the ACRP-MDP Exam

The ACRP-MDP exam certifies clinical research professionals with specialized knowledge in medical device clinical trials. Covering five content areas including ethical considerations, device regulations, GCP operations, site management, and research design, this specialty credential is referenced to ICH Guidelines and ISO 14155:2011.

Questions

60 scored questions

Time Limit

90 minutes

Passing Score

Scaled score 600 (200-800 scale)

Exam Fee

$250 (members) / $300 (non-members) (ACRP (Association of Clinical Research Professionals))

ACRP-MDP Exam Content Outline

25%

Ethical and Participant Safety Considerations

Informed consent, adverse event reporting, IRB oversight, risk-benefit analysis, vulnerable populations, and the Belmont Report principles applied to device trials

10%

Investigational Product/Device Regulations

FDA device classification, IDE requirements, 510(k) pathway, PMA process, De Novo classification, UDI system, EU MDR, design controls, and quality systems

30%

Clinical Trial Operations (GCPs)

ICH E6 GCP principles, ISO 14155, sponsor and investigator responsibilities, risk management (ISO 14971), design controls, source documentation, and regulatory oversight

30%

Study and Site Management

Device accountability, monitoring activities, site initiation and close-out, protocol compliance, data management, essential documents, record keeping, and CAPA

Scientific Concepts and Research Design

Study endpoints, biocompatibility (ISO 10993), study design (adaptive, crossover, single-arm with OPC), statistical analysis plans, and blinding challenges in device trials

How to Pass the ACRP-MDP Exam

What You Need to Know

Passing score: Scaled score 600 (200-800 scale)
Exam length: 60 questions
Time limit: 90 minutes
Exam fee: $250 (members) / $300 (non-members)

Keys to Passing

Complete 500+ practice questions
Score 80%+ consistently before scheduling
Focus on highest-weighted sections
Use our AI tutor for tough concepts

ACRP-MDP Study Tips from Top Performers

1Focus 60% of your study time on Clinical Trial Operations (GCP) and Study/Site Management, which together make up 60% of the exam content

2Master the differences between SR and NSR device studies, including the IDE requirements and approval pathways for each

3Study the ISO standards thoroughly: ISO 14155 (clinical investigations), ISO 14971 (risk management), ISO 10993 (biocompatibility), and ISO 13485 (quality management)

4Review the UADE reporting timeline (10 working days) and MDR requirements, as adverse event reporting is heavily tested

5Compare FDA and EU MDR regulatory frameworks side by side, including 510(k), PMA, De Novo, CE marking, Notified Bodies, and EUDAMED

Frequently Asked Questions

How many questions are on the ACRP-MDP exam?

The ACRP-MDP exam consists of 60 multiple-choice questions, of which 10 are unscored pre-test items that do not affect your score. You have 90 minutes to complete all 60 questions.

What score do I need to pass the ACRP-MDP exam?

ACRP reports exam scores on a 200-800 scale. The minimum passing scaled score is 600. One point is granted for each correct answer with no penalty for incorrect answers.

Who is eligible to take the ACRP-MDP exam?

You must hold an active ACRP certification (CCRC, CPI, ACRP-CP, or CCRA) to sit for the ACRP-MDP specialty exam. Additionally, you must attest to 3,000 hours of experience performing tasks outlined in the ACRP-MDP Detailed Content Outline.

How much does the ACRP-MDP exam cost in 2026?

The exam fee is $250 for ACRP members and $300 for non-members. There is no separate application fee for the MDP specialty exam. ACRP membership is $160/year.

What changes are coming to the ACRP-MDP exam in 2026?

Beginning July 15, 2026, the ICH E6(R3) Guideline for Good Clinical Practice will replace E6(R2) across all ACRP examinations, including the ACRP-MDP. Candidates testing in the Fall 2026 window should study E6(R3).

How does the ACRP-MDP differ from other ACRP certifications?

The ACRP-MDP is a specialty credential focused specifically on medical device clinical trials, including IDE regulations, device classifications, PMA/510(k) pathways, and ISO 14155. Other ACRP certifications (ACRP-CP, CCRA, CCRC, CPI) cover general clinical research and are prerequisites for the MDP.

How do I maintain my ACRP-MDP certification?

Maintenance of certification is required every 2 years. You must earn 24 contact hours/points through continuing education activities or retake the current certification exam during your renewal period.