Glossary of Medical Device Industry Terms

123 - A | B - D | E- G | H - L | M - P | Q - S | T - V W - Z

483 - Form FDA 483, "Notice of Inspectional Observations," is a form used by the US FDA to document and communicate concerns discovered during facility inspections. Also referred to as "Form 483" or merely "483".

510(k) - One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a510(k) with the Food and Drug Administration (FDA). Also known as a "Premarket Notification" a 510(k) notification allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Any device that reaches market via 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device").

513(g) - Section 513(g) of the Federal Food, Drug, and Cosmetic Act specifies that a person can submit a written request to the FDA seeking classification confirmation of a device for which the classification is unclear.

90/385/EEC - See AIMDD

93/42/EEC - See MDD

98/79/EC - See IVDD

ACE - Adverse Clinical Event

ACT - Applied Clinical Trials

AFSSAPS - Agence Française de Sécurité Sanitaire des Produits de Santé (France)

AIMDD - The Active Implantable Medical Device Directive, 90/385/EEC, covers the placing on the market and putting into service of active implantable medical devices.

ANSI - American National Standards Institute

ANVISA - The National Health Surveillance Agency (in Portuguese, Agência Nacional de Vigilância Sanitária, ANVISA) is an autonomous organ of the government of Brazil. It is "an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates.

ASL - Approved Supplier List

ASQC - American Society for Quality Control

Australian Sponsor - An Australian Sponsor is a representative appointed by a non-Australian medical device and IVD manufacturer to act as a contact liaison with the Therapeutic Goods Administration (TGA). An Australian Sponsor must be a resident of Australia or maintain a place of business in Australia.

BOM - Bill of Materials

BSI - British Standards Institute

CA - A Competent Authority is the Department (Ministry) of Health of an EU Member State.

CAPA -Corrective and Preventive Action

CAR - Corrective Action Request or Corrective Action Record

CCC Mark - The China Compulsory Certificate mark, commonly known as CCC Mark, is a safety mark for many products sold on the Chinese market. As of 2013, medical devices do not require this certification.

CDC - Center for Disease Control & Prevention (USA)

CDRH - Center for Devices and Radiological Health (USA)

CE Marking - The CE Marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. By affixing the CE marking to a product, the manufacturer declares that it meets EU safety, health and environmental requirements.

CEN - Communité Européenne des Normes (European Committee for Standardization)

CFR – Code of Federal Regulations (USA)

CFU - Colony Forming Unit (used in Gamma validation)

cGMP - Current Good Manufacturing Practices. See GMP.

cGMPR - Current Good Manufacturing Practice Regulations

Clinical Trial - Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Clinical Trial Sponsor - The Clinical Trial Sponsor is responsible for the safety of subjects in a clinical trial and informs local site investigators of the true historical safety record of the drug, device or other medical treatment to be tested, and of any potential interactions of the study treatment(s) with already approved medical treatments.

CMDCAS - Canadian Medical Devices Conformity Assessment System

CMDR - Canadian Medical Device Regulation

CR – Change Request

CRF - Change Request Form

CRO - A Contract Research Organization, also called a Clinical Research Organization, is a service organization that provides support to the pharmaceutical and biotechnology industries. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research and development process.

cGLP - Current Good Laboratory Practice (USA)

CSR - Customer Service Representative

DCMS - Design Change Master Sheet

Design Dossier - See Technical File.

DHF - Device History File

DHHS - Department of Health and Human Services (U.S.)

DHR - Device History Record

DIMDI - Deutsches Institut für Medizinische Dokumentation und Information (German Institute of Medical Documentation and Information)

DIMS - Design Input Master Sheet

DMAH - The Pharmaceutical Affairs Law (PAL) requires that all medical device, IVD and pharmaceutical companies without a location in Japan appoint a Designated Marketing Authorization Holder.

DMR - Device Master Record

DRG - Diagnosis Related Group (DRG) is a system to classify hospital cases into one of approximately 500 groups, also referred to as DRGs, expected to have similar hospital resource use, developed for Medicare as part of the prospective payment system.

DRMS - Deisgn Review Master Sheet

DTC - Design Transfer Checklist

DVerMS - Design Verification Master Sheet

DVMS - Design Validation Master Sheet

EC REP - A European Authorized Representative (EC REP) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.

EDMA - European Diagnostic Manufacturer's Association

EEA - The European Economic Area includes the 27 European Member States plus Iceland, Liechtenstein and Norway.

EEC - European Economic Community, also referred to as the European Community, which has now become part of the European Union.

EFTA - The European Free Trade Association is a free trade organization between four European Countries (Iceland, Liechtenstein, Norway and Switzerland) that operates parallel to, and is linked to, the European Union.

eLabeling - With the release of European MEDDEV 2.14/3 REV 1 in 2007, the European Commission now allows In-Vitro Diagnostics (IVD) companies with products intended for professional use only to place Instructions for Use online instead of including a printed booklet inside the product packaging.

EMC - Electro-Magnetic Compatibility

EN - European Standards (EN) for various sectors that were created by the European Committee for Standardization (CEN). Some standards are voluntary, whereas other standards are mandatory under EU law.

EU - The European Union is an economic and political union of 27 Member States.

EUCOMED - European Confederation of Medical Associations

EUDAMED - European Database on Medical Devices

FDA - The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

FMEA - Failure Mode and Effects Analysis

FOIA - Freedom of Information Act (USA)

FTA - Fault Tree Analysis

Gap Analysis - Gap analysis is a tool that helps a company to compare its actual performance with its potential performance.

GCP - Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial, assurance of the safety and efficacy of the newly developed compounds, and standards on how clinical trials should be conducted.

GHTF - Global Harmonization Task Force

GMP - Good Manufacturing Practice refers to the quality system requirements for medical device (and other) companies outlined by the US FDA in 21 CFR Part 820. Also referred to as the Quality System Regulation (QSR).

GOST - GOST refers to a set of technical standards maintained by the Euro-Asian Council for Standardization, Metrology and Certification (EASC), a regional standards organization operating under the auspices of the Commonwealth of Independent States (CIS).

Green Dot - The Green Dot (German: Der Grüne Punkt) is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods as per the European "Packing and Packaging Waste Directive - 94/62/EC." This applies to medical devices as well.

Health Canada - Health Canada is the official regulatory agency that reviews medical devices to assess their safety, effectiveness and quality before they are authorized for sale in Canada.

ID - Identification

IDE - An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).

IFU - Instructions for Use

ISO 13485 - ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

ISO 14971 - ISO 14971 is an ISO standard, published in 2007, that represents the requirements for a risk management system for medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.

ISO 9001 - ISO 9001 is an ISO standard that represents the requirements for quality management systems. It is used across industries and is not specific to medical devices like ISO 13485.

IVD - IVitro Diagnostic tests are medical devices intended to perform diagnoses from assays in a test tube, or more generally in a controlled environment outside a living organism.

IVDD - The IVitro Diagnostic Device Directive delineates requirements that in vitro diagnostic devices must meet before they can be sold in the EU market.

MDD - The Medical Device Directive is intended to harmonize the laws relating to medical devices within the European Union. Medical Device Directive 93/42/EEC was most recently reviewed and amended by 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.

MDEL - A Medical Device Establishment License is a certification issued by Health Canada. Class I medical device manufacturers must secure a MDEL if selling directly to Canadian consumers and not through a distributor.

MDMA - Medical Device Manufacturer's Association

MDR - Medical Device Report (USA)

MDUFMA - Medical Device User Fee and Modernization Act of 2002 (USA)

MDV - Medical Device Vigilance (EU)

Medical Device - A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery.

MHRA - The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Ministry of Health - The health department (or Ministry of Health ) is a part of the government which focuses on issues related to the general health of the citizenry.

MPR - Medical Problem Report (Canada)

MR - Management Representative

MSDS - Material Safety Data Sheet

NCR - Non-Conformance Report

NIH - National Institutes of Health (U.S.)

Notified Body - A Notified Body, in the European Union, is an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture.

NPRA - New Product Risk Assessment

OSHA - Occupational Safety and Health Administration (USA)

OTC - Over the Counter (Patient Use Instructions)

PMA - Premarket approval by FDA is the required process of scientific review to guarantee safety and effectiveness for Class III devices.

PMDA - The Pharmaceutical and Medical Devices Agency in Japan reviews applications for marketing approval of pharmaceuticals and medical devices. It also monitors their post-marketing safety and provides relief compensation for people who have suffered from adverse drug reactions from pharmaceuticals or infections from biological products.

PMS - Post Marketing Surveillance is the practice of monitoring a pharmaceutical drug or device after it has been released on the market.

PO - Purchase Order

PRMS - Product Requirements Master Sheet

QA - Quality Assurance refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

QMS - Quality Management System can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.

QP - Companies that intend to manufacture or import medicinal products or intermediate products, for use in clinical trials or for market within the EU, must appoint the service of a Qualified Person, in order to comply with EU Good Manufacturing Practice Standards.

QPM - Quality Policy Manual

QSP - Quality System Procedure

QSR - Quality System Regulations. See GMP.

RA - Return Authorization. Can also refer to "Regulatory Affairs."

RA - Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

Registered Certification Body Japan - Independent companies authorized by the MHLW to certify Specified Controlled Medical Devices and issue Pre-Market Certifications.

Registrar - See Notified Body.

SOP- Standard Operating Procedure

SRW - Shipping Receiving Warehouse

STED - A Summary TEchnical Document (STED) is a standardized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to standardize regulatory submissions for many countries.

Technical File - A Technical File (called a Design Dossier for Class III devices) is a comprehensive collection of documents that demonstrates a product's technical basis for conformity to the applicable directive(s). It is required by the CE Marking Directive.

TGA - The Therapeutic Goods Administration is a unit of the Australian Government Department of Health and Ageing that regulates medical devices, IVDs and drugs in Australia.

US Agent - A US Agent is a representative is appointed by a non-US medical device of IVD manufacturer to act as a contact liaison with the US FDA. A US Agent must be a resident of the United States or maintain a place of business in the US.

USP - United States Pharmacopoeia

Validation - Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.

Warning Letter - A warning letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.

WHO - World Health Organization

WI - Work Instructions

WTO - World Trade Organization