Medtech glossary: Medical device terms, abbreviations and acronyms

August 9, 2023 By Jim Hammerand

[Illustration by wladimir1804 via Adobe Stock]

3D printing: A type of additive manufacturing used to make patient-specific anatomical models, device prototypes and finished medical devices.

3TG: This is an abbreviation for tantalum, tin, tungsten and gold, which are some of the most commonly used conflict minerals in medical device manufacturing.

510(k): FDA clearance under Section 510(k) of the Food, Drug and Cosmetic Act authorizes a company to sell a Class I, II, or III medical device based on substantially equivalent predicate devices

AbbVie: This Abbott pharma spinoff gets its name from its former parent company — one of the world’s largest medical device companies — and “vie,” which Abbott said references the Latin root “vi” meaning “life.

ADA: The American Diabetes Association’s annual scientific sessions meeting is referred to as ADA.

AdvaMed: The Advanced Medical Technology Association, an organization that represents medical device makers

AFib: Atrial fibrillation is an irregular heart rhythm (arrhythmia) with a rapid heartbeat (tachycardia) that may be temporary or permanent. A variety of devices monitor, detect, diagnose and treat AFib, which is associated with cardiac complications such as heart failure and stroke.

AI: Artificial intelligence in medtech is exploding as device developers — including developers of algorithms and software-as-a-medical-device — find new or improved methods for diagnosis, patient monitoring, procedures and more efficient workflows.

Association of Medical Device Reprocessors: The AMDR represents organizations engaged in commercial reprocessing and remanufacturing of medical devices for re-use.

BD: Becton, Dickinson and Co. is one of the world’s largest medical device manufacturers.

BCI: Brain-computer interface systems monitor and collect brain signals (usually with an electrode brain implant) to relay commands for patients who have lost neuromuscular functions.

CAD: Coronary artery disease

CAPA: Corrective and preventive action

CDMO: Contract development and manufacturing organization, a third-party outsourcing partner that designs and makes medical devices or components for medtech developers and OEMs

CD: Chlorine dioxide (ClO₂) is a gas used to sterilize medical devices.

CDRH: The FDA Center for Devices and Radiological Health reviews medical devices and radiation-emitting products.

CGM: Continuous glucose monitor, used for diabetes

Class I, II and III: The FDA uses three class levels to categorize the risk level of devices and recall. However, while a Class I recall is the most dangerous and a Class III recall the least dangerous, a Class I device is considered the lowest risk for patient health while Class III devices pose the greatest risk and are subject to the most regulatory oversight.

CMO: Contract manufacturing organization, a third-party outsourcing partner that makes components or devices for medtech developers and OEMs. CMO is also an abbreviation for two executive titles in a medical device company’s management: chief medical officer and chief marketing officer.

Combination products/devices: These medical products use a combination of drugs, devices, and/or biological products for therapies and diagnostics. Examples include pre-filled drug syringes, antibiotic-coated implants, inhalers and microneedle patches.

Complaint files: The FDA requires medical device manufacturers to retain files of all complaints and establish and maintain procedures for receiving, reviewing, and evaluating complaints.

CRO: Contract research organization, a third party that provides medical device developers and manufacturers with outsourced research services

De novo: De novo classification from the FDA allows a medical device company to market a novel Class I or II device.

DHF: A design history file is a compilation of records describing the design history of a finished device. The FDA requires medical device manufacturers maintain this information.

DHR: A device history record is a compilation of records containing the production history of a finished device. The FDA requires medical device manufacturers maintain this information.

DMR: A device master record is a compilation of records containing the procedures and specifications for a finished device. The FDA requires medical device manufacturers maintain this information.

ECG/EKG: Electrocardiogram, a device for monitoring and recording heart signals

EFS: An early feasibility study is described by the FDA as “a limited clinical investigation of a device early in development” to evaluate and improve device design for more efficient product development.

Electron-beam sterilization: Also called e-beam sterilization, this is one of the fastest-growing methods of sterilizing medical devices.

Embecta: The name of this BD diabetes care business spinoff includes “em” for empathy for those living with diabetes, and “bect” for former parent company Becton, Dickinson & Co.

ESG: Environmental, social and governance, a corporate function focused on sustainability, ethics and decision-making

EtO: Ethylene oxide is a gas used to sterilize around half of all medical devices.

FAERS: The FDA Adverse Event Reporting System is a database of adverse event reports, medication error reports and product quality complaints submitted to FDA.

FDA: The U.S. Food & Drug Administration

FMEA: Failure Mode and Effect Analysis proactively identifies and addresses potential problems with a medical device before they arise to mitigate those failures.

Harmonization by Doing: HBD is a collaboration between the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to expedite medical device approvals in both countries.

Human factors: This element of medical device design and engineering considers how physicians, patients, caregivers and other users interact with a particular product to ensure it works safely and intuitively.

HUD: Humanitarian use device designation is an FDA approval pathway for medical devices that may help people with rare diseases or conditions, defined as those affecting no more than 8,000 people in the U.S. per year.

IDE: Investigational device exemption from the FDA permits the use of an investigational device in a clinical study to collect data on the product’s safety and effectiveness.

IFU: Instructions for use tell a patient or caregiver how to use a device, including set-up, operation, cleaning, troubleshooting and storage.

IVD: In vitro diagnostic

IVDR: The European Commission’s In Vitro Diagnostics Regulation

IVL: Intravascular lithotripsy is a way to treat arterial calcification with sonic pressure waves.

J&J: Johnson & Johnson is the world’s second-largest medical device company through its Johnson & Johnson MedTech unit, formerly Johnson & Johnson Medical Devices.

MDUFA: Medical Device User Fee Amendments allow the FDA to collect fees from medical device manufacturers to fund device review and regulation.

Medtech: Medical technology

Medical Device Regulation: The European Union’s Medical Device Regulation is commonly abbreviated as MDR.

Medical Device Reporting: MDR is one of the FDA’s tools to monitor medical device performance and safety issues.

Medtronic: The world’s largest medical device company by revenue was founded in 1949 as a medical electronics repair business.

Nitinol: A nickel-titanium alloy with shape memory properties that make it useful in many medtech applications.

OEM: Original equipment manufacturer is an entity such as Medtronic that makes its own components or devices, versus a CMO that manufactures those products on behalf of an OEM.

PAD: Peripheral artery disease

PMA: Premarket approval is the FDA’s review process for Class III medical devices, which are those that support or sustain life, are substantially important in preventing health impairment or pose the greatest risk of serious injury or death.

PMDA: The Pharmaceuticals and Medical Devices Agency is Japan’s version of the FDA.

Postmarket surveillance: Defined by the FDA as “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”

QMS/QS/QSR: A medical device manufacturer’s quality management system (QMS), quality system (QS) and quality system record (QSR) are all regulated by the FDA, which requires all medical device manufacturers to maintain a QSR.

RDN: Renal denervation is a treatment for hypertension that applies electricity to deactivate nerves in the arteries that carry blood to the kidneys. Renal denervation systems have won approval in the E.U., but not in the U.S.

R&D: Research and development (see the top medtech R&D spenders here)

Reprocessing: A process for cleaning and disinfecting or sterilizing medical devices for re-use, including certain single-use devices under FDA standards.

RWD: Real-world data is defined by FDA as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWD sources include electronic health records, medical claims, product or disease registries, and digital health technologies such as apps or smart sensors.

RWE: Real-world evidence is clinical evidence of a device’s safety and/or effectiveness collected derived from analysis of real-world data (RWD).

SaMD: Software-as-a-medical-device is software with a medical purpose that’s not part of a physical medical device.

SCD: The Selective Cytopheretic Device is made by SeaStar Medical for extracorporeal therapy to treat hyperinflammation.

SCG: Seismocardiogram, a device for monitoring and recording heart vibrations

TCET: Transitional Coverage for Emerging Technologies, a new pathway proposal for Medicare coverage of breakthrough devices

TCT: The Transcatheter Cardiovascular Therapeutics conference is the annual meeting of the Cardiovascular Research Foundation (CRF) for interventional cardiovascular medicine.

TAVR: Transcatheter aortic valve replacement is a minimally invasive procedure to replace a heart valve with an implant delivered by catheter rather than open-heart surgery.

UDI: Unique device identifier, required by the FDA on medical devices to track each individual unit from manufacturing through distribution and use

ZB: Zimmer Biomet is one of the world’s largest medical device companies and the third-largest orthopedics manufacturer.

ZimVie: The name of Zimmer Biomet’s spine and dental businesses spinoff is a combination of “Zim” from its former parent company and “Vie,” the French word for “life.” ZimVie is one of the world’s largest medical device manufacturers.

This post was originally published in July 2023 and was updated with new entries in August 2023.