Regulatory Glossary

A premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

Any undesirable experience associated with the use of a medical product. For medical devices, this includes malfunction, injury, or death.

A regional framework for the regulation of medical devices across ASEAN member countries, promoting harmonization and mutual recognition.

A secure, time-stamped record that tracks the sequence of activities affecting a specific operation, procedure, or event in a regulated environment.

The database of therapeutic goods approved for supply in Australia, maintained by the Therapeutic Goods Administration (TGA).

The population of viable microorganisms on a raw material, component, finished product, or package before sterilization.

The ability of a material to perform with an appropriate host response when applied as intended. Essential for devices that contact body tissues.

An FDA program for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

A certification mark indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.

A document issued by a regulatory authority certifying that a product is freely sold in the country of origin and meets all regulatory requirements.

A document summarizing the clinical evidence demonstrating safety and performance of a medical device throughout its lifecycle.

A systematic study of a medical device in human subjects to evaluate safety and effectiveness under controlled conditions.

A product comprised of two or more regulated components (drug/device, biologic/device, drug/biologic, or all three) combined as a single entity.

The process used to demonstrate that specified requirements relating to a product, process, system, or body are fulfilled.

A systematic approach to identifying the root causes of quality problems and taking corrective action to prevent recurrence.

An FDA pathway for novel low-to-moderate risk devices that are not substantially equivalent to a predicate device.

A compilation of records containing the complete design history of a finished device, required by FDA 21 CFR Part 820.

A compilation of records containing procedures and specifications for a finished device, including device specifications and quality assurance procedures.

The convergence of digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery.

The ability of a device to function satisfactorily without introducing intolerable electromagnetic disturbances to other equipment in its vicinity.

Performance of a clinical function necessary to achieve freedom from unacceptable clinical risk as identified by the manufacturer.

A low-temperature sterilization method using ethylene oxide gas, commonly used for heat-sensitive medical devices.

The EU agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union.

A form issued by FDA investigators at the conclusion of an inspection to document objectionable conditions or practices observed.

Action taken by a manufacturer to reduce the risk of death or serious deterioration in health associated with a device already on the market.

Registration requirement for manufacturers located outside the country where they intend to market their medical devices.

International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.

Standards for ensuring that the quality and integrity of medical products is maintained throughout the distribution chain.

A system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use.

An internationally standardized system of names and numbers to classify traded products, used for customs and import/export purposes.

Singapore's regulatory agency for health products including pharmaceuticals, medical devices, and blood products.

The application of knowledge about human capabilities and limitations to the design of devices to optimize safety and effectiveness.

Official authorization required to import medical devices or pharmaceuticals into a country, often held by a local authorized representative.

Medical devices used on samples taken from the human body (such as blood, urine, tissue) to detect diseases, conditions, or infections.

EU Regulation 2017/746 establishing rules for in vitro diagnostic medical devices placed on the market in the European Union.

The objective intent of the manufacturer regarding the use of a product as reflected in specifications, instructions, and labeling.

A voluntary group of medical device regulators from around the world working to accelerate international medical device regulatory harmonization.

International standard specifying requirements for a quality management system for the design and manufacture of medical devices.

Japan's regulatory agency responsible for pharmaceuticals, medical devices, and regenerative medicine products.

South Korea's Ministry of Food and Drug Safety, responsible for regulating food, drugs, medical devices, and cosmetics.

All labels and other written, printed, or graphic matter upon a device or its containers or wrappers, or accompanying such device.

The natural or legal person responsible for design, manufacture, packaging, and labeling of a device before it is placed on the market.

A local entity authorized to hold the product registration and is responsible for regulatory compliance within that jurisdiction.

A person or entity required in certain jurisdictions to represent foreign manufacturers and serve as a local contact for regulatory authorities.

An instrument, apparatus, machine, or implant intended for use in diagnosis, treatment, or prevention of disease, not achieving its purpose through pharmacological means.

EU Regulation 2017/745 on medical devices, replacing the previous Medical Device Directive (MDD) with more stringent requirements.

A program that allows a single regulatory audit of medical device manufacturers to satisfy the requirements of multiple regulatory jurisdictions.

China's regulatory authority responsible for drugs, medical devices, and cosmetics, formerly known as CFDA.

An organization designated by an EU member state to assess conformity of medical devices before being placed on the European market.

A company that produces parts or equipment that may be marketed by another manufacturer under their own brand name.

A continuous process to collect and evaluate clinical data from devices already on the market to confirm safety and performance.

A systematic process to collect and analyze relevant data on medical devices after they have been placed on the market.

A legally marketed device to which a new device is compared in a 510(k) submission to establish substantial equivalence.

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

A formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives.

Action taken by a manufacturer to remove or correct a marketed product that violates laws or poses a risk to health.

The process of officially recording a medical device with regulatory authorities before it can be legally marketed in that jurisdiction.

Systematic use of available information to identify hazards and to estimate risk associated with a medical device.

Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.

Software intended to be used for medical purposes without being part of a hardware medical device.

The probability of a single viable microorganism occurring on an item after sterilization, typically expressed as 10^-6.

A determination by FDA that a device is at least as safe and effective as a legally marketed predicate device.

A standardized format for organizing technical documentation developed by IMDRF to facilitate regulatory submissions.

Comprehensive compilation of documents demonstrating conformity of a medical device with applicable regulatory requirements.

Documentation that contains or refers to information enabling conformity assessment to be carried out.

Australia's regulatory body for therapeutic goods including prescription medicines, medical devices, and biologicals.

A framework for regulating medical devices throughout their entire lifecycle from design to discontinuation.

The ability to track medical devices and materials throughout the manufacturing and distribution chain for safety and recall purposes.

A system for uniquely identifying medical devices through distribution and use, facilitating traceability and post-market surveillance.

The U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other products.

Application of knowledge about human behavior, abilities, and limitations to the design of tools and systems.

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled for a particular intended use.

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

The collection, detection, assessment, and prevention of adverse effects related to medical devices after they have entered the market.

An official FDA communication notifying a company of serious regulatory violations that require immediate corrective action.

The procurement, holding, supply, or export of medical products for the purpose of resale to other businesses.