Medical Device Regulatory Glossary

An undesirable clinical occurrence associated with the use of a medical device, including injury, illness, or death. Manufacturers must report adverse events to regulatory authorities within prescribed timeframes.

A chronological record of activities that provides documentary evidence of the sequence of events. In post-market surveillance, audit trails prove that signals were collected, evaluated, and acted upon by identified personnel.

The ability of a medical device material to perform with an appropriate host response when applied as intended. Biocompatibility testing evaluates cytotoxicity, sensitization, irritation, and systemic toxicity.

A systematic process for investigating root causes of nonconformities, implementing corrections to prevent recurrence (corrective action), and eliminating potential causes before they occur (preventive action). CAPA is a core element of any quality management system.

FDA risk-based classification system. Class I devices pose the lowest risk and are subject to general controls. Class II devices require special controls (typically a 510(k) clearance). Class III devices pose the highest risk and require premarket approval (PMA).

The process of receiving, reviewing, evaluating, and documenting complaints about a marketed device. Each complaint must be evaluated to determine if it represents a reportable event under MDR requirements.

An action taken to eliminate a detected nonconformity in a distributed device without physically removing it from the market. A correction might include relabeling, software updates, or user notifications. Distinct from a recall, which involves removing or halting distribution.

A regulatory pathway for novel, low-to-moderate risk devices that have no legally marketed predicate. De Novo creates a new classification regulation and product code, which can then serve as a predicate for future 510(k) submissions.

The registration of medical devices with a regulatory authority. In the US, manufacturers must list each device with the FDA. In Canada, the Medical Device Licence (MDL) database contains all listed devices. TrueMedDevice tracks 142K+ Health Canada device listings.

The FDA's electronic system for submitting mandatory medical device reports. Manufacturers, importers, and device user facilities submit adverse event and malfunction reports through the eMDR gateway in a structured XML format.

Regulatory action taken by an authority against a non-compliant device or manufacturer. FDA enforcement actions include warning letters, seizures, injunctions, and civil/criminal penalties. TrueMedDevice monitors 38K+ FDA enforcement records.

The United States federal agency responsible for regulating medical devices, drugs, biologics, and food safety. The Center for Devices and Radiological Health (CDRH) within FDA oversees medical device premarket review, post-market surveillance, and enforcement.

An action taken by a manufacturer to reduce a risk of death or serious deterioration of health associated with a device that is already on the market. FSCAs include recalls, modifications, device destruction, or updated instructions for use.

A licence issued by Health Canada authorizing the sale of a medical device in Canada. The MDALL (Medical Device Active Licence Listing) database contains all active licences. TrueMedDevice tracks 73K+ active MDALL licence records.

The Canadian federal department responsible for regulating medical devices, drugs, and health products. The Medical Devices Bureau within the Therapeutic Products Directorate oversees device licensing, recalls, and post-market surveillance in Canada.

The ongoing state of preparedness for a regulatory audit or inspection. For post-market surveillance, inspection readiness means having documented evidence that external signals were monitored, evaluated by qualified personnel, and that decisions were traced and justified.

The international standard specifying quality management system requirements for organizations involved in the design, production, installation, and servicing of medical devices. ISO 13485 certification is recognized by most regulatory authorities worldwide.

A premarket submission to FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. Most Class II devices require 510(k) clearance before marketing. TrueMedDevice tracks 174K+ 510(k) clearance records from the FDA database.

The failure of a device to meet its performance specifications or to perform as intended. Certain malfunctions are reportable under MDR if the malfunction would likely cause or contribute to a death or serious injury if it were to recur.

The FDA's database of medical device adverse event reports submitted by manufacturers, importers, device user facilities, and voluntary reporters. MAUDE contains millions of reports and is a primary source for post-market signal detection.

The FDA's mandatory reporting requirement for manufacturers, importers, and device user facilities. MDR requires reporting of device-related deaths, serious injuries, and certain malfunctions within prescribed timeframes (30 days for deaths/serious injuries, 5 days for emergencies).

An international program that allows a single audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory authorities (FDA, Health Canada, ANVISA, TGA, and MHLW/PMDA).

The most stringent type of FDA premarket review, required for Class III devices that pose the highest risk. PMA requires valid scientific evidence demonstrating safety and effectiveness. TrueMedDevice tracks 54K+ PMA approval records including supplements.

The systematic monitoring and evaluation of medical device performance after the device has been placed on the market. PMS includes collecting and analyzing adverse event reports, complaint data, recalls, field safety actions, and scientific literature to ensure continued safety and effectiveness.

A legally marketed device to which a new device is compared in a 510(k) submission to demonstrate substantial equivalence. The predicate establishes the baseline intended use and technological characteristics against which the new device is evaluated.

A three-letter FDA code identifying a specific device category (e.g., DXY for electrocardiograph software). Product codes determine the applicable classification regulation, review requirements, and recognized standards for a device type.

The FDA's updated quality system regulation (effective February 2026) that harmonizes with ISO 13485:2016. QMSR replaces the previous Quality System Regulation (21 CFR 820) and aligns FDA requirements with the international standard used globally.

The organizational structure, responsibilities, procedures, processes, and resources needed to implement quality management. For medical devices, the quality system must cover design controls, production, CAPA, complaint handling, and post-market surveillance as required by applicable regulations.

An action taken to remove or correct a marketed device that violates FDA regulations or is defective. Recalls are classified as Class I (most serious, reasonable probability of serious adverse health consequences), Class II (temporary or reversible), or Class III (unlikely to cause adverse health consequences). TrueMedDevice monitors 57K+ FDA recall records and 10K+ Health Canada recall notices.

The physical withdrawal of a device from its point of use to a location designated by the manufacturer. Under FDA regulations, removals must be reported unless the removal was for stock recovery, routine servicing, or improvement unrelated to a violation.

The systematic application of policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk associated with a medical device throughout its lifecycle. ISO 14971 provides the framework for risk analysis, risk evaluation, risk control, and residual risk assessment.

An FDA authority under Section 522 of the FD&C Act that requires manufacturers to conduct post-market surveillance studies for certain Class II and III devices. These studies collect safety and effectiveness data after market clearance or approval.

Any piece of regulatory intelligence from an official source that may be relevant to a manufacturer's device or product portfolio. Signals include new recalls, enforcement actions, clearances, approvals, adverse event reports, and licence changes. TrueMedDevice collects signals from 10 official FDA and Health Canada sources.

The regulatory determination that a new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness. Substantial equivalence is the basis for 510(k) clearance.

The statistical analysis of complaint and adverse event data over time to detect increasing frequencies or emerging patterns that may indicate a systemic issue. Trending analysis is a key element of post-market surveillance and can trigger CAPA actions.

The process of rapidly assessing incoming regulatory signals to determine their relevance, priority, and required action. In TrueMedDevice, signal triage assigns a relevance score (HIGH, MID, LOW) based on product code matches, keyword relevance, signal type, and recency.

A direct URL from an evidence card back to the original record on the issuing authority's website (e.g., openFDA, Health Canada). Verify links allow auditors and reviewers to independently confirm the source data, supporting the audit trail and data integrity requirements.

The systematic process of collecting, reporting, and evaluating post-market incidents involving medical devices. Vigilance is the international term (used by IMDRF, EU, and Health Canada) corresponding to FDA's Medical Device Reporting (MDR) requirements.