ACRP-MDP flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Medical device definition

An instrument, apparatus, implement, machine, implant, reagent, software, or material intended by its manufacturer for a medical purpose such as diagnosis, prevention, monitoring, treatment, or alleviation of disease.

In vitro diagnostic device

A device intended to examine specimens derived from the human body to provide information about physiological or pathological states, congenital abnormalities, safety, or compatibility with potential recipients.

Significant risk device

An investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject and therefore requires an IDE and full IRB review.

Non-significant risk device

An investigational device that does not pose a serious risk to subjects and is studied under abbreviated requirements, including IRB approval and informed consent without an IDE.

510(k) premarket notification

A premarket submission demonstrating that a new device is substantially equivalent to a legally marketed predicate device in intended use and technological characteristics.

Premarket approval (PMA)

The FDA pathway for Class III devices requiring valid scientific evidence providing a reasonable assurance of safety and effectiveness before marketing.

Primary endpoint

The prespecified outcome that answers the primary study hypothesis and typically drives the sample size calculation and statistical analysis plan.

Surrogate endpoint

A laboratory measurement or biomarker used as a substitute for a clinically meaningful endpoint to predict benefit or harm, such as HbA1c for diabetes outcomes.

Clinical investigation plan

The document describing the rationale, objectives, design, methods, statistical considerations, monitoring, and record-keeping for a medical device clinical investigation.

Vulnerable subjects

Individuals whose willingness to volunteer may be unduly influenced by expectation of benefit or fear of reprisal, such as prisoners, employees, students, or cognitively impaired persons.

Single-blind design

A study design in which one party, usually the subject, is unaware of treatment assignment while the investigator or assessor knows the assignment.

Double-blind design

A study design in which both the subject and the investigator or outcome assessor are unaware of treatment assignment, reducing bias in outcome measurement.

Open-label investigation

A study in which all parties know the treatment assignment, often used when device characteristics or procedural requirements make masking impractical.

ISO 14155 scope

The international standard specifying good clinical practice requirements for designing, conducting, recording, and reporting clinical investigations of medical devices in human subjects.

ICH E6 alignment

ICH E6 provides good clinical practice principles for trials; ISO 14155:2026 aligns device investigation terminology and expectations with these principles while addressing device-specific requirements.

Informed consent timing

Consent must be obtained and documented before any investigation-specific procedure is performed, after the subject receives adequate information about risks, benefits, and alternatives.

Ethics committee approval

Approval by an independent ethics committee or IRB must be obtained before the investigation begins and before implementing substantive amendments to the clinical investigation plan.

Sponsor responsibilities

The sponsor ensures a quality management system, develops the CIP, selects investigators, monitors the investigation, manages safety reporting and device accountability, and may delegate duties in writing.

Investigator responsibilities

The investigator conducts the investigation per the CIP, obtains consent, records source data, reports adverse events, ensures device accountability, and retains essential records.

Serious adverse event

An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability, or is a congenital anomaly.

Serious adverse device effect

An adverse event related to the investigational device that meets seriousness criteria, including device malfunction or misuse that could have led to a serious outcome.

Device deficiency

An inadequacy of a medical device related to its identity, quality, durability, reliability, safety, or performance, including malfunction, use error, or labeling inadequacy.

Device accountability

The documented tracking of investigational device shipment, receipt, use, return, and disposal to ensure only enrolled subjects receive devices and quantities reconcile.

Risk-based monitoring

A monitoring approach that allocates oversight resources according to risks to subject safety and data quality, rather than uniform on-site visits for all sites.

Source document verification

The monitor's comparison of data recorded in the case report form against original source documents to confirm accuracy, completeness, and consistency.

Essential documents

Records demonstrating the investigation's conduct and quality, including the CIP, ethics approvals, consent forms, investigator CVs, device records, CRFs, and safety reports.

Record retention period

The required duration for maintaining investigation records after completion or termination, set by applicable regulation and the CIP, often at least two years after the last approval.

Protocol deviation

Any departure from the clinical investigation plan that does not meet the criteria for a protocol violation; it is documented, assessed for impact, and reported per the CIP.

Protocol violation

A significant departure from the CIP that may affect subject safety, rights, or data integrity, requiring prompt reporting to the sponsor and ethics committee.

Investigational device exemption

A regulatory authorization permitting an investigational device to be shipped and used in a clinical study to gather safety and effectiveness data before marketing approval.

Clinical investigation report

The final document prepared by the sponsor summarizing the investigation's rationale, methods, results, and conclusions, including safety and device performance data.

Substantial equivalence

A regulatory determination that a new device has the same intended use and comparable technological characteristics as a predicate device, supporting clearance via 510(k).