Medical Device Glossary

Abbreviated 510(k)Part of 510(k)US Relies on FDA guidance documents, special controls, or voluntary consensus standards. The submitter provides summary reports or declarations of conformity. If the FDA finds the submission unsuitable, the FDA converts it to a Traditional 510(k) and keeps the original receipt date. FDA, How to Prepare an Abbreviated 510(k) (content current as of 06/28/2024) Read more → AdulteratedUS Section 501(h) of the Federal Food, Drug, and Cosmetic Act makes a device adulterated when its manufacture, packing, storage, or installation does not conform to the quality system requirements. Introducing an adulterated device into interstate commerce is a prohibited act. 21 CFR 820.10(e); Federal Food, Drug, and Cosmetic Act section 501(h) Read more → Adverse Event ReportingUS · EU · CA The reports a manufacturer, and in some regimes an importer, must send a regulator about problems with a device. 21 CFR Part 803; Regulation (EU) 2017/745, Article 87; Medical Devices Regulations (SOR/98-282), sections 59 and 60 Read more → Advisory NoticeGlobal A notice a manufacturer issues after delivery of a medical device to give supplementary information or to advise on the device's use, modification, return to the manufacturer, or destruction. ISO 13485:2016 clause 3.1; 21 CFR 820.10(b)(4) Read more → Authorized RepresentativeEU A person established in the Union who has accepted a written mandate from a manufacturer outside the Union to act on its behalf for specified EU MDR tasks. Regulation (EU) 2017/745, Article 2(32) Read more →

CAPAGlobal The paired process of corrective action, which removes the cause of a nonconformity that has occurred, and preventive action, which removes the cause of one that could occur. ISO 13485 requires both under clauses 8.5.2 and 8.5.3 but does not name the pair. ISO 13485:2016 clauses 8.5.2 and 8.5.3; no standard defines the pair Read more → CE MarkEU The marking by which a manufacturer indicates that a device conforms to the applicable requirements of the EU MDR and other Union harmonization legislation. Custom-made and investigational devices do not bear it. Regulation (EU) 2017/745, Article 2(43); Article 20(1) Read more → Class I RecallUS The most serious recall class. The FDA assigns it where there is a reasonable probability that using or being exposed to the violative product will cause serious adverse health consequences or death. 21 CFR 7.3(m)(1) Read more → Class II RecallUS The middle recall class. The FDA assigns it where using or being exposed to the violative product may cause temporary or medically reversible adverse health consequences. The class also applies where the probability of serious adverse health consequences is remote. 21 CFR 7.3(m)(2) Read more → Class III RecallUS The least serious recall class. The FDA assigns it where using or being exposed to the violative product is not likely to cause adverse health consequences. 21 CFR 7.3(m)(3) Read more → Clinical EvaluationEU A systematic and planned process of continuously generating, collecting, analyzing, and assessing clinical data on a device. The purpose is to verify the device's safety and performance, including clinical benefits, when used as the manufacturer intends. The results are documented in a clinical evaluation report. Regulation (EU) 2017/745, Article 2(44); Article 61(12) Read more → ComplaintGlobal Any communication that alleges a deficiency in a released device or related service, such as its quality, safety, usability, or performance. A complaint can be written, electronic, or oral. Part 820 requires a manufacturer to keep complaint records. ISO 13485:2016 clause 3.4; 21 CFR 820.35(a) Read more → CorrectionGlobal Action taken to eliminate a detected nonconformity itself. Rework and regrading are examples. A correction does not address the cause and can be taken before, with, or after a corrective action. ISO 9000:2015 clause 3.12.3, as applied by 21 CFR 820.3 Read more → Correction and RemovalUS Two actions a manufacturer takes on a device already distributed. A correction acts on the device where it is used, such as a repair in the field. A removal takes the device from its point of use to another location for actions such as repair, relabeling, or destruction. 21 CFR 806.2(d) and (j); 21 CFR 806.10 Read more → Corrective ActionGlobal Action taken to remove the cause of a nonconformity so that it does not recur. Corrective action works on the cause, whereas a correction works on the nonconformity itself. ISO 13485:2016 clause 8.5.2; ISO 9000:2015 clause 3.12.2 Read more →

Design and Development FileGlobal The file that holds or points to the records showing a device's design and development met requirements. The records include the design and development plan and the procedures followed. ISO 13485:2016 clause 7.3.10 Read more → Design ChangeGlobal A change to a device's design after the design inputs are set. The change must be identified, reviewed, and approved before implementation. Verification and validation apply as appropriate. ISO 13485:2016 clause 7.3.9 Read more → Design ControlsLegacy termUS · Global The Quality System Regulation's requirements for controlling a device's design, from planning through design transfer. Records were kept in the design history file. Part 820 now meets the same need through ISO 13485 clause 7.3. 21 CFR 820.10(c); ISO 13485:2016 clause 7.3 Read more → Design History FileLegacy termUS A compilation of records the Quality System Regulation required for each device type, showing that the design followed the approved design plan and the regulation. The design and development file now serves this purpose. ISO 13485:2016 clause 7.3.10; 89 FR 7496, response to comment 31 Read more → Design InputGlobal The physical and performance requirements of a device that serve as the basis for its design. Design verification confirms that the design outputs meet them. ISO 13485:2016 clause 7.3.3; definition as in 21 CFR 820.3(f) before February 2, 2026 Read more → Design OutputGlobal The results of design work at each phase and at its end, which must meet the design input requirements. The finished design output is the basis for the medical device file. ISO 13485:2016 clause 7.3.4; definition as in 21 CFR 820.3(g) before February 2, 2026 Read more → Design ReviewGlobal A documented, systematic examination of a design at planned stages to evaluate whether it meets its requirements and to identify problems. ISO 13485:2016 clause 7.3.5; definition as in 21 CFR 820.3(h) before February 2, 2026 Read more → Design TransferGlobal The documented process that translates approved design outputs into production specifications, so that the device can be manufactured as designed. ISO 13485:2016 clause 7.3.8; definition as in 21 CFR 820.30(h) before February 2, 2026 Read more → Design ValidationGlobal Establishing by objective evidence that the finished device meets user needs and its intended use. ISO 13485:2016 clause 7.3.7; definition as in 21 CFR 820.3(z)(2) before February 2, 2026 Read more → Design VerificationGlobal Confirmation, by objective evidence, that the design outputs meet the design input requirements. ISO 13485:2016 clause 7.3.6; definition as in 21 CFR 820.30(f) before February 2, 2026 Read more → Device ClassificationUS · EU The sorting of medical devices into risk-based classes. The US has Classes I to III. The EU has classes I, IIa, IIb, and III. Each regime sets its own criteria. 21 CFR 860.3(c); Regulation (EU) 2017/745, Article 51(1) Read more → Device Classification (EU)Part of Device ClassificationEU The EU MDR divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risk. The classes come from 22 rules in Annex VIII. The manufacturer states the class and the rules applied in the technical documentation. Regulation (EU) 2017/745, Article 51(1); Annex VIII, Chapter III; Annex II, Section 1.1(f) (consolidated text of 10 January 2025) Read more → Device Classification (US)Part of Device ClassificationUS The FDA's three classes for devices, set by whether general or special controls give reasonable assurance of safety and effectiveness. Class I needs general controls only. Class II needs special controls as well. Class III needs premarket approval. 21 CFR 860.3(c) Read more → Device History RecordLegacy termUS A record the Quality System Regulation required to show that each batch, lot, or unit was made in accordance with its device master record. Its content now sits largely in the medical device file or the batch record under ISO 13485 clause 7.5.1. ISO 13485:2016 clause 7.5.1; 21 CFR 820.35(c); 89 FR 7496, response to comment 31 Read more → Device Master RecordLegacy termUS A record the Quality System Regulation required for each device type. The record compiled the device specifications and the production procedures. The record also held the quality assurance, packaging, labeling, and servicing procedures. The medical device file now serves this purpose. ISO 13485:2016 clause 4.2.3; 89 FR 7496, response to comment 31 Read more → Distributor (EU)EU A natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. Regulation (EU) 2017/745, Article 2(34) (consolidated text of 10 January 2025) Read more → Document ControlGlobal Procedures that control the documents a quality management system requires. The controls cover approval, review, change identification, and keeping obsolete versions out of use. ISO 13485:2016 clause 4.2.4 Read more →

Economic Operator (EU)EU Under the EU MDR, a manufacturer, an authorized representative, an importer, a distributor, or the person who assembles systems and procedure packs under Article 22(1) and (3). Regulation (EU) 2017/745, Article 2(35) (consolidated text of 10 January 2025) Read more → Effectiveness CheckGlobal Objective evidence gathered after a corrective or preventive action is implemented, to show that the cause was removed and the nonconformity has not recurred. In a recall the term means something different: verifying that consignees received the recall notice and acted on it. ISO 13485:2016 clauses 8.5.2(f) and 8.5.3(e); 21 CFR 7.42(b)(3) for the recall meaning; no standard defines the phrase for corrective and preventive action Read more → EU MDREU Regulation (EU) 2017/745, the European Union regulation on medical devices for human use. The regulation governs placing devices on the market, making them available, and putting them into service. EU MDR repealed Council Directives 90/385/EEC and 93/42/EEC. Regulation (EU) 2017/745, Article 1(1) Read more →

Field Safety Corrective ActionEU Corrective action a manufacturer takes for technical or medical reasons to prevent or reduce the risk of a serious incident with a device on the market. Users and customers are told through a field safety notice. Regulation (EU) 2017/745, Article 2(68) and (69) Read more → Finished DeviceUS Any device or accessory to a device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. 21 CFR 820.3(a) Read more → Form 483US The list of observations an investigator from the FDA gives a firm's management at the end of an inspection. The list covers conditions that may violate the Federal Food, Drug, and Cosmetic Act. A Form 483 is not a final determination by the FDA that a violation exists. FDA Form 483 Frequently Asked Questions Read more →

HarmGlobal Injury or damage to the health of people, or damage to property or the environment. ISO 14971:2019 clause 3.3 Read more → HazardGlobal A potential source of harm. A hazard exists whether or not anyone is exposed to it. ISO 14971:2019 clause 3.4 Read more → Hazardous SituationGlobal A circumstance in which people, property, or the environment are exposed to one or more hazards. ISO 14971:2019 clause 3.5 Read more →

Importer (EU)EU A natural or legal person established within the Union that places a device from a third country on the Union market. Regulation (EU) 2017/745, Article 2(33) (consolidated text of 10 January 2025) Read more → Incident Reporting (CA)Part of Adverse Event ReportingCA A manufacturer and an importer must each give the Minister a preliminary and a final report on an incident in Canada involving a device sold there. The incident must relate to a device failure or inadequate labeling, and have led to death or a serious deterioration in health, or could if it recurred. Medical Devices Regulations (SOR/98-282), sections 59 and 60 (current as of 1 November 2026) Read more → Inspection ClassificationUS The final result the FDA assigns to an inspected facility: NAI, VAI, or OAI. The FDA usually sends the classification to the firm in a letter within 45 to 90 days of the close of the inspection, depending on the inspection type. FDA, Inspection Classification Database (content current as of 09/13/2024) Read more → Intended Purpose (EU)EU The use for which a device is intended according to the data the manufacturer supplies on the label, in the instructions for use, or in promotional or sales materials or statements, and as the manufacturer specifies in the clinical evaluation. Regulation (EU) 2017/745, Article 2(12) (consolidated text of 10 January 2025) Read more → ISO 13485Global The international quality management system standard for medical device organizations. Part 820 incorporates by reference its third edition, dated March 1, 2016. 21 CFR 820.7(b); 21 CFR 820.1(b) Read more → ISO 13485 Clause 4Part of ISO 13485Global General requirements for documenting and maintaining the quality management system: its processes, outsourced processes, software validation, and the documentation it needs, including the quality manual and records. ISO 13485:2016, clause 4 Read more → ISO 13485 Clause 5Part of ISO 13485Global What top management must do for the quality management system: commitment, customer and regulatory requirements, the quality policy and objectives, responsibilities and authorities, and management review. ISO 13485:2016, clause 5 Read more → ISO 13485 Clause 6Part of ISO 13485Global The resources the quality management system needs: providing resources, personnel competence, infrastructure, and the work environment. ISO 13485:2016, clause 6 Read more → ISO 13485 Clause 7Part of ISO 13485Global Planning and performing product realization, from planning and customer requirements through design and development, purchasing, and production and service provision, to controlling monitoring and measuring equipment. ISO 13485:2016, clause 7 Read more → ISO 13485 Clause 8Part of ISO 13485Global Measurement, analysis, and improvement: feedback, complaints, internal audits, nonconforming product, data analysis, and corrective and preventive action. ISO 13485:2016, clause 8 Read more →

Licensing (CA)Part of Registration and LicensingCA Canada requires an establishment license to import or sell a medical device, with exceptions for retailers, health care facilities, and certain manufacturers. No one may import or sell a Class II, III, or IV device unless its manufacturer holds a medical device license for it. Medical Devices Regulations (SOR/98-282), sections 26, 32, and 44 (current as of 1 November 2026) Read more →

Management ReviewGlobal Top management's planned review of the quality management system at set intervals, to confirm that the system remains suitable, adequate, and effective. ISO 13485:2016 clause 5.6, Management review Read more → ManufacturerUS · EU · CA The party a device regulation holds responsible for a device. 21 CFR 820.3(b); Regulation (EU) 2017/745, Article 2(30); Medical Devices Regulations (SOR/98-282), section 1 Read more → Manufacturer (CA)Part of ManufacturerCA A person who sells a medical device under their own name or a mark they own or control, and who is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying it, or for assigning it a purpose. The person may perform those tasks or have others perform them. Medical Devices Regulations (SOR/98-282), section 1 (definition of manufacturer; current as of 1 November 2026) Read more → Manufacturer (EU)Part of ManufacturerEU A natural or legal person who manufactures or fully refurbishes a device, or has one designed, manufactured, or fully refurbished, and markets it under its own name or trade mark. Regulation (EU) 2017/745, Article 2(30) and (31) (consolidated text of 10 January 2025) Read more → Manufacturer (US)Part of ManufacturerUS Any person who designs, makes, assembles, or processes a finished device. Under Part 820 the term also covers contract sterilization, installation, and relabeling. The term extends to remanufacturers, repackers, specification developers, and initial distributors of foreign entities. 21 CFR 820.3(b) Read more → Market WithdrawalUS A firm's removal or correction of a distributed device for no violation, or for a minor violation the FDA would not take legal action on. Normal stock rotation is an example. A market withdrawal is not a recall. 21 CFR 806.2(i); 21 CFR 7.3(j) Read more → MDR Annex I (GSPR)Part of EU MDREU The EU MDR's list of general safety and performance requirements for devices. It runs in three chapters: general requirements, requirements for design and manufacture, and requirements for the information supplied with the device. Regulation (EU) 2017/745, Annex I (consolidated text of 10 January 2025) Read more → MDR Annex II (Technical Documentation)Part of EU MDREU The content a manufacturer's technical documentation must include. The documentation has to be clear, organized, readily searchable, and unambiguous. It runs in six sections, from the device description to verification and validation. Regulation (EU) 2017/745, Annex II (consolidated text of 10 January 2025) Read more → MDR Annex III (Post-Market Surveillance Documentation)Part of EU MDREU The content of the technical documentation on post-market surveillance, drawn up under Article 83 through Article 86. It starts with the post-market surveillance plan required by Article 84. Regulation (EU) 2017/745, Annex III (consolidated text of 10 January 2025) Read more → MDR Annex IV (Declaration of Conformity)Part of EU MDREU The information an EU declaration of conformity must contain. It includes the manufacturer's name and address, a statement that the manufacturer alone is responsible for issuing the declaration, and the Basic UDI-DI. Regulation (EU) 2017/745, Annex IV (consolidated text of 10 January 2025) Read more → MDR Annex V (CE Marking)Part of EU MDREU The form of the CE marking: the initials CE in a set graduated shape. The parts must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum may be waived for small-scale devices. Regulation (EU) 2017/745, Annex V (consolidated text of 10 January 2025) Read more → MDR Annex VI (Registration and UDI)Part of EU MDREU Registration information for devices and economic operators, the core data elements given to the UDI database with the UDI-DI, and the UDI system itself. Regulation (EU) 2017/745, Annex VI (consolidated text of 10 January 2025) Read more → MDR Annex VII (Notified Body Requirements)Part of EU MDREU The requirements a notified body must meet. They fall into four groups: organizational and general requirements, quality management requirements, resource requirements, and process requirements. Regulation (EU) 2017/745, Annex VII (consolidated text of 10 January 2025) Read more → MDR Annex VIII (Classification Rules)Part of EU MDREU The rules that sort devices into class I, IIa, IIb, or III. Chapter I defines terms such as duration of use, Chapter II covers applying the rules, and Chapter III sets out 22 classification rules. Regulation (EU) 2017/745, Annex VIII (consolidated text of 10 January 2025) Read more → MDR Annex IX (QMS and Technical Documentation Assessment)Part of EU MDREU Conformity assessment based on a quality management system and on assessment of technical documentation. Chapter I covers the quality management system, Chapter II the assessment of technical documentation, and Chapter III administrative provisions. Regulation (EU) 2017/745, Annex IX (consolidated text of 10 January 2025) Read more → MDR Annex X (Type-Examination)Part of EU MDREU Conformity assessment in which a notified body ascertains and certifies that a device fulfils the relevant provisions of the Regulation. The body examines the technical documentation, the relevant life cycle processes, and a representative sample of the planned production. Regulation (EU) 2017/745, Annex X (consolidated text of 10 January 2025) Read more → MDR Annex XI (Product Conformity Verification)Part of EU MDREU Conformity assessment that ensures devices conform to the type certified under Annex X and meet the Regulation's provisions that apply to them. Part A covers production quality assurance and Part B covers product verification. Regulation (EU) 2017/745, Annex XI (consolidated text of 10 January 2025) Read more → MDR Annex XII (Notified Body Certificates)Part of EU MDREU Certificates a notified body issues: among the general requirements, a certificate must be in an official language of the Union, refer to only one conformity assessment procedure, and be issued to only one manufacturer. Regulation (EU) 2017/745, Annex XII (consolidated text of 10 January 2025) Read more → MDR Annex XIII (Custom-Made Devices)Part of EU MDREU The procedure for custom-made devices. The manufacturer or its authorized representative draws up a statement. The statement gives the manufacturer's details, data identifying the device, and a declaration that the device is for the exclusive use of a particular patient or user. Regulation (EU) 2017/745, Annex XIII (consolidated text of 10 January 2025) Read more → MDR Annex XIV (Clinical Evaluation and PMCF)Part of EU MDREU Clinical evaluation in Part A and post-market clinical follow-up in Part B. Regulation (EU) 2017/745, Annex XIV (consolidated text of 10 January 2025) Read more → MDR Annex XV (Clinical Investigations)Part of EU MDREU Clinical investigation requirements. Chapter I sets general requirements, Chapter II covers the documentation for the application for a clinical investigation, and Chapter III covers the sponsor's other obligations. Regulation (EU) 2017/745, Annex XV (consolidated text of 10 January 2025) Read more → MDR Annex XVI (Products Without a Medical Purpose)Part of EU MDREU The list of groups of products without an intended medical purpose that Article 1(2) brings under the Regulation. Examples include contact lenses and items introduced into or onto the eye. Regulation (EU) 2017/745, Annex XVI (consolidated text of 10 January 2025) Read more → Medical Device FileGlobal The file a manufacturer keeps for each medical device type or family. The file holds or points to the specifications, procedures, and records that show the device conforms to ISO 13485 and to applicable regulatory requirements. ISO 13485:2016 clause 4.2.3 Read more → Medical Device ReportPart of Adverse Event ReportingUS A report to the FDA from a manufacturer, importer, or device user facility. The report is required when a device may have caused or contributed to a death or serious injury. A malfunction that would likely cause one if it recurred also triggers the report. Part 803 sets the report types and deadlines. 21 CFR Part 803; 21 CFR 803.3 Read more →

No Action Indicated (NAI)Part of Inspection ClassificationUS Shows a facility is in an acceptable state of compliance. The facility usually did not receive a Form 483 at the end of the inspection. FDA, Inspection Classification Database (content current as of 09/13/2024) Read more → Nonconforming ProductGlobal A product that does not meet a specified requirement. ISO 13485 clause 8.3 requires the manufacturer to identify it and control it so that it is not used or delivered unintentionally. ISO 13485:2016 clauses 8.3.1 and 8.3.2; ISO 9000:2015 clause 3.6.9 Read more → NonconformityGlobal A requirement that has not been met, whether the requirement is stated, generally implied, or obligatory. ISO 9000:2015 clause 3.6.9, applied through 21 CFR 820.3 and ISO 13485:2016 clause 3 Read more → Notified BodyEU A conformity assessment body designated under the EU MDR. For devices that need third-party assessment, its certificate is required before the CE mark can be affixed. The CE mark is then followed by the body's identification number. Regulation (EU) 2017/745, Article 2(42) Read more →

Official Action Indicated (OAI)Part of Inspection ClassificationUS Shows a facility is in an unacceptable state of compliance. The facility may have received a Form 483 at the end of the inspection. FDA, Inspection Classification Database (content current as of 09/13/2024) Read more →

Post-Market SurveillanceEU Activities a manufacturer performs with other economic operators to set up and maintain a systematic procedure. The procedure proactively collects and reviews experience from devices on the market, so that any need for immediate corrective or preventive action is identified. Regulation (EU) 2017/745, Article 2(60) Read more → Preventive ActionGlobal Action taken to remove the cause of a potential nonconformity or other potential undesirable situation so that it does not occur. Preventive action works before any nonconformity exists. ISO 13485:2016 clause 8.5.3; ISO 9000:2015 clause 3.12.1 Read more → Process ValidationGlobal Establishing by objective evidence that a process consistently produces a result or product that meets its predetermined specifications. Validation is required where a process's output cannot be fully verified by later inspection or testing. ISO 13485:2016 clause 7.5.6; definition as in 21 CFR 820.3(z)(1) before February 2, 2026 Read more → Purchasing ControlsGlobal The procedures that ensure purchased product and services meet specified requirements. They include evaluating, monitoring, and re-evaluating suppliers in proportion to the effect of their product on the finished device. ISO 13485:2016 clause 7.4, Purchasing Read more →

QMSRUS The FDA's Quality Management System Regulation, 21 CFR Part 820, in effect since February 2, 2026. The regulation requires a documented quality management system that meets ISO 13485:2016 together with the additional requirements Part 820 sets. 21 CFR 820.10(a) Read more → QMSR Section 820.1 (Scope)Part of QMSRUS The scope section of Part 820. The part covers the methods, facilities, and controls used to design, manufacture, package, label, store, install, and service finished devices for human use. Contract sterilizers, relabelers, repackers, remanufacturers, and initial distributors of foreign entities that perform those functions are included. 21 CFR 820.1(a) Read more → QMSR Section 820.7 (Incorporation by Reference)Part of QMSRUS Incorporates two ISO documents into Part 820 by reference, each at a stated edition: ISO 13485:2016, third edition, and clause 3 of ISO 9000:2015, fourth edition. 21 CFR 820.7 Read more → QMSR Section 820.10 (Quality Management System)Part of QMSRUS The core requirement of Part 820. A manufacturer must document a quality management system that meets the applicable requirements of ISO 13485 and the other applicable requirements of the part. It also ties named ISO clauses to other regulations in Title 21. 21 CFR 820.10 Read more → QMSR Section 820.35 (Control of Records)Part of QMSRUS Adds record content the FDA requires beyond ISO 13485 clause 4.2.5: required content for complaint, servicing, and UDI records, and a way to mark confidential records to help the FDA decide on disclosure. 21 CFR 820.35 Read more → QMSR Section 820.45 (Device Labeling and Packaging Controls)Part of QMSRUS Adds labeling and packaging controls beyond ISO 13485 clause 7.5.1. A manufacturer must document procedures for the integrity, inspection, storage, and operations of labeling and packaging, and examine labeling for accuracy before release or storage. 21 CFR 820.45 Read more → Quality Management SystemUS The documented processes, procedures, and records a manufacturer establishes and maintains to assure that its finished devices are safe and effective. Part 820 requires the system to fit the specific devices the manufacturer makes. 21 CFR 820.1(a) Read more → Quality System RegulationLegacy termUS The name of 21 CFR Part 820 before February 2, 2026, when the Quality Management System Regulation replaced it. The regulation set the FDA's current good manufacturing practice requirements for finished devices. 21 CFR 820.1(a) Read more →

RecallUS A firm's removal or correction of a marketed product that the FDA considers in violation of the laws it administers and would take legal action against, such as seizure. Market withdrawals and stock recoveries are not recalls. The FDA assigns each recall to Class I, II, or III by health hazard. 21 CFR 7.3(g) Read more → Recall ClassificationUS The Class I, II, or III designation the FDA assigns to a recall to show the relative health hazard of the recalled product. Class I is the most serious and Class III the least. 21 CFR 7.3(m) Read more → Recall Classification (CA)Part of RecallCA Health Canada's Type I, II, or III designation shows the relative health hazard of a recalled product. The company running the recall assigns the type from a health risk assessment. Health Canada checks that the assigned type is appropriate. Health Canada, What is a Recall? (hazard classification, the criteria); Recall policy for health products (POL-0016), which has the responsible party assign the type and Health Canada check it. The older definitions page says the Branch assigns the type Read more → Recall Classification (EU)Part of RecallEU The EU MDR sets no recall classes. It defines a recall as returning a device already made available to the end user, and a withdrawal as stopping a device in the supply chain from being made available. Regulation (EU) 2017/745, Article 2(62), (63), (68), and (69); a search of the consolidated text found no recall classes (consolidated text of 10 January 2025) Read more → Recall Classification (US)Part of RecallUS The Class I, II, or III designation the FDA assigns to a product recall to show the relative health hazard of the recalled product. The FDA makes the assignment, not the recalling firm. Class I is the most serious and Class III the least. 21 CFR 7.3(m) Read more → Registration (EU)Part of Registration and LicensingEU Before placing a device on the market, a manufacturer, authorized representative, or importer registers in the EU electronic system and receives a single registration number (SRN). The manufacturer also assigns each device a Basic UDI-DI and provides it to the UDI database. Changes to the registration must be updated within one week. Regulation (EU) 2017/745, Articles 29 and 31 (consolidated text of 10 January 2025) Read more → Registration and LicensingUS · EU · CA What each regime requires a device business to file with the regulator, and what it requires for each device. The US requires establishment registration and device listing. The EU requires registration of manufacturers, authorized representatives, importers, and devices in an electronic system. Canada requires establishment licenses and medical device licenses. 21 CFR 807.20; Regulation (EU) 2017/745, Articles 29 to 31; Medical Devices Regulations (SOR/98-282), sections 26 and 44 Read more → Registration and ListingPart of Registration and LicensingUS Two linked FDA requirements. Owners or operators of device establishments register the establishments and list the devices they have in commercial distribution. 21 CFR 807.20 Read more → Residual RiskGlobal The risk that remains after risk control measures have been implemented. ISO 14971:2019 clauses 3.17 and 8 Read more → ReworkGlobal Action taken on a nonconforming product so that it fulfills the specified requirements in the medical device file before it is released for distribution. 21 CFR 820.3(b) Read more → RiskGlobal The combination of the probability of occurrence of harm and the severity of that harm. ISO 14971:2019 clause 3.18; ISO 13485:2016 clause 3.17 Read more → Risk ControlGlobal The process of deciding on and implementing measures that reduce risk to specified levels or keep it within them. ISO 14971:2019 clause 3.21; order of priority in clause 7.1 Read more → Risk ManagementGlobal The systematic process of analyzing, evaluating, controlling, and monitoring risk throughout a device's life cycle. ISO 14971:2019 clause 3.24; ISO 13485:2016 clause 7.1 Read more → Risk to HealthUS Under 21 CFR Part 806, the hazard level that triggers reporting of a correction or removal. Two cases qualify. One is a reasonable probability of serious adverse health consequences or death. The other is a possibility of temporary or medically reversible consequences, or of an outcome where serious consequences are remote. 21 CFR 806.2(k) Read more → Root CauseGlobal The underlying reason a nonconformity occurred, determined so that removing it prevents recurrence. Restating the nonconformity is not a root cause. No standard defines the term. ISO 13485 clause 8.5.2 requires the cause to be determined. ISO 13485:2016 clause 8.5.2(b); neither ISO 9000:2015 nor ISO 13485:2016 defines the term in clause 3 Read more →

Serious IncidentEU Any incident that directly or indirectly led, might have led, or might lead to one of three outcomes. The outcomes are death, a serious deterioration in health, and a serious public health threat. Regulation (EU) 2017/745, Article 2(65) Read more → Serious Incident ReportPart of Adverse Event ReportingEU A manufacturer's report of a serious incident to the competent authorities. The deadline is 15 days after the manufacturer becomes aware of the incident. The deadline shortens to 10 days for a death or an unanticipated serious deterioration in health, and to 2 days for a serious public health threat. Regulation (EU) 2017/745, Article 87(3) to (5) Read more → SeverityGlobal A measure of the possible consequences of a hazard. ISO 14971:2019 clause 3.27 Read more → Special 510(k)Part of 510(k)US For a change a manufacturer makes to its own legally marketed device. Verification and validation under design controls can support the substantial equivalence decision for certain changes. FDA, How To Prepare A Special 510(k) (content current as of 06/28/2024) Read more →

Technical DocumentationEU The documentation a manufacturer must draw up and keep current to show a device conforms to the EU MDR. Annex II sets the content in six sections, from the device description to verification and validation. Annex III adds post-market surveillance documentation. Regulation (EU) 2017/745, Article 10(4); Annexes II and III; Article 2 does not define the term Read more → Traditional 510(k)Part of 510(k)US Usable under any circumstance to seek marketing authorization through the 510(k) program. Special and Abbreviated 510(k)s are used only when a submission meets certain factors. FDA, How to Prepare a Traditional 510(k) (content current as of 12/14/2023); 21 CFR 807.87 Read more →

Unique Device IdentifierUS · EU A code that identifies a specific device through its distribution and use. The US and the EU define the term; Canada's Medical Devices Regulations do not use it. 21 CFR 830.3; Regulation (EU) 2017/745, Article 2(15); Medical Devices Regulations (SOR/98-282), full text searched for the term, none found (1 November 2026) Read more → Unique Device Identifier (EU)Part of Unique Device IdentifierEU A series of numeric or alphanumeric characters, created through internationally accepted device identification and coding standards, that allows unambiguous identification of specific devices on the market. Under the EU MDR the UDI has two parts, a device identifier and a production identifier. Regulation (EU) 2017/745, Article 2(15); Article 27(1); Article 29(1) (consolidated text of 10 January 2025) Read more → Unique Device Identifier (US)Part of Unique Device IdentifierUS A code that identifies a device through its distribution and use. The device identifier is fixed and identifies the version or model and the labeler. The production identifier varies and can show the lot, serial number, expiration date, or manufacture date. 21 CFR 830.3 Read more →

Voluntary Action Indicated (VAI)Part of Inspection ClassificationUS Objectionable conditions or practices were found, but the FDA decided the facility can correct them voluntarily and recommends no action. The facility usually received a Form 483. FDA, Inspection Classification Database (content current as of 09/13/2024) Read more →

Warning LetterUS A formal notice from the FDA that a company or individual has significant violations of federal requirements. The letter asks for a written response within a stated time. Failure to correct the violations may lead to further enforcement action. About Warning and Close-Out Letters Read more →

510(k)US A premarket submission that shows a device is substantially equivalent to a legally marketed predicate device. It contains the information required by 21 CFR 807.87. The FDA accepts three types: Traditional, Special, and Abbreviated. 21 CFR 807.87; FDA, Premarket Notification 510(k) and How to Prepare a Traditional 510(k) (content current as of 12/14/2023) Read more →