Acronyms
MedTech Acronyms, A to Z
220 abbreviations used across 13 areas of MedTech, each with what it stands for and a link to the full definition. Search by the letters, by the words behind them, or by topic.
220 of 220 acronyms. Browse the full glossary.
#5 acronyms
- 340B340B Drug Pricing ProgramFederal program providing discounted drugs to safety-net providers.
- 3P 510(k)Third-Party Review of 510(k)Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types.
- 510(k)510(k) Premarket NotificationFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
- 513(g)513(g) Request for InformationFormal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
- 524BSection 524B of the FD&C ActThe federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A9 acronyms
- AAMIAAMIStandards body for medical instrumentation; co-publisher of ISO/IEC adoptions.
- ACNUAdditional Condition for Nonprescription UseFDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider.
- ACPAlgorithm Change ProtocolThe detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented.
- AEAdverse EventAny untoward medical occurrence in a subject, whether or not related to the device.
- AKSAnti-Kickback StatuteU.S. criminal statute prohibiting remuneration to induce federal healthcare business.
- ANVISAANVISABrazil's National Health Surveillance Agency, regulating medical devices and IVDs.
- APCAmbulatory Payment ClassificationThe Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient.
- ASCAAccreditation Scheme for Conformity AssessmentFDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
- ATT&CKMITRE ATT&CKKnowledge base of real-world adversary tactics, techniques, and procedures organized into a matrix used to model threats and assess defenses.
B3 acronyms
- BDDBreakthrough Device DesignationFDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
- BIMBudget Impact ModelFinancial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon.
- BOMBill of MaterialsStructured list of every component, sub-assembly, and quantity needed to manufacture a device.
C25 acronyms
- Cap TableCapitalization TableLedger of all securities issued by a company and who owns them.
- CAPACorrective and Preventive ActionSystematic process to investigate and resolve quality issues and prevent recurrence.
- CCIContainer Closure IntegrityDemonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life.
- CDSClinical Decision SupportSoftware providing healthcare professionals with knowledge and patient-specific information.
- CDxCompanion DiagnosticIVD that identifies patients who will benefit from a specific drug.
- CDxCompanion Diagnostic (IVDR)IVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response.
- CECPClinical Evaluation Consultation ProcedureMDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices.
- CEDCoverage with Evidence DevelopmentMedicare paradigm conditioning coverage on participation in approved clinical studies or registries.
- CEPClinical Evaluation PlanEU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
- CERClinical Evaluation ReportDocumented assessment of clinical data demonstrating EU MDR conformity for a device.
- CIPClinical Investigation PlanEU MDR's term for the protocol document governing a clinical investigation of a device.
- CLIAClinical Laboratory Improvement AmendmentsU.S. federal standards that govern clinical laboratory testing.
- CLSIClinical and Laboratory Standards InstituteUS-based consensus standards organization whose documents establish widely used analytical and clinical laboratory performance evaluation protocols for IVDs.
- CPTCurrent Procedural Terminology CodesAMA-maintained codes used to report medical procedures and services for billing.
- CPTCPT CodesAMA-maintained codes that describe medical procedures and services.
- CRFCase Report FormStructured paper or electronic forms used to capture protocol-required data for each enrolled subject.
- CRMCardiac Rhythm ManagementImplantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.
- CROContract Research OrganizationService organization providing clinical trial management and supporting services to sponsors.
- CSCommon SpecificationsMandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.
- CSCommon Specifications (IVDR)Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.
- CVCCorporate Venture CapitalVenture arms of strategic MedTech and pharma companies investing in adjacent or complementary innovation.
- CVDCoordinated Vulnerability DisclosureA documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.
- CVECommon Vulnerabilities and ExposuresA globally unique identifier for a publicly disclosed cybersecurity vulnerability.
- CVSSCommon Vulnerability Scoring SystemAn industry-standard 0–10 score that quantifies the severity of a software vulnerability.
- CWECommon Weakness EnumerationCommunity-maintained list of software and hardware weakness types, the underlying defects that cause CVEs.
D10 acronyms
- D3FENDMITRE D3FENDMITRE's knowledge graph of defensive cybersecurity countermeasures, explicitly mapped to the ATT&CK techniques they mitigate.
- DCTDecentralized Clinical TrialA trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
- De NovoDe Novo Classification RequestPathway to classify novel low- to moderate-risk devices that lack a predicate.
- DHFDesign History FileCompilation of records describing the design history of a finished device.
- DHRDevice History RecordRecords demonstrating that a device is manufactured per the DMR.
- DMEPOSDurable Medical Equipment, Prosthetics, Orthotics, and SuppliesMedicare benefit category covering durable medical equipment, prosthetics, orthotics, and supplies, billed under HCPCS Level II codes through DME MACs.
- DMRDevice Master RecordCompilation of records containing the procedures and specifications for a finished device.
- DSMBData Safety Monitoring BoardIndependent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.
- DTxDigital TherapeuticSoftware-based intervention that delivers evidence-based therapy to prevent, manage, or treat a disease.
- DTxDigital TherapeuticsSoftware-based interventions that prevent, manage, or treat disease.
E11 acronyms
- E6(R3)ICH E6(R3) Good Clinical PracticeRevision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023.
- EC REPAuthorized Representative (EU)Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.
- ECO / ECNEngineering Change Order / NoticeDocuments that authorize and communicate changes to released designs, BOMs, or manufacturing processes.
- EDCElectronic Data CaptureSoftware systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
- EFSEarly Feasibility StudyFDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
- eIFUElectronic Instructions for UseProvision of IFU in electronic form instead of, or in addition to, paper.
- eMDRElectronic Medical Device ReportingFDA's mandatory electronic submission system for Medical Device Reports.
- EPElectrophysiologyDiagnosis and catheter-based treatment of cardiac arrhythmias.
- ePROElectronic Patient-Reported OutcomeA patient-reported outcome instrument administered and captured electronically, subject to validation and 21 CFR Part 11 data-integrity requirements when used in FDA-regulated trials.
- EUAEmergency Use AuthorizationFDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.
- EURLEU Reference Laboratory (EURL)Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice.
F8 acronyms
- FCEField Clinical EngineerManufacturer representative providing clinical and technical support in the OR or cath lab.
- FedRAMPFedRAMPU.S. government-wide program that standardizes security assessment, authorization, and continuous monitoring for cloud services sold to federal agencies.
- FIHFirst-in-Human StudyFirst clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.
- FMEAFailure Mode and Effects AnalysisBottom-up technique for systematically identifying potential failures and their effects.
- FRIAFundamental Rights Impact AssessmentAssessment deployers of certain high-risk AI systems must complete before first use.
- FSCAField Safety Corrective ActionAction taken to reduce a risk of serious deterioration in health associated with a device.
- FTAFault Tree AnalysisTop-down deductive analysis tracing how faults can combine to cause an undesired event.
- FTOFreedom to OperateAnalysis of whether a product can be sold without infringing third-party IP.
G8 acronyms
- GCPICH E6 Good Clinical PracticeInternational standard for the design, conduct, and reporting of clinical trials.
- GCPGood Clinical PracticeInternational quality standard for designing and conducting clinical trials.
- GMLPGood Machine Learning PracticeGuiding principles for the development of AI/ML-enabled medical devices.
- GPAIGeneral-Purpose AI ModelAI model trained on broad data at scale that displays significant generality and can be integrated into many downstream systems.
- GPOGroup Purchasing OrganizationEntity that aggregates hospital purchasing to negotiate prices with suppliers.
- GSPRGeneral Safety and Performance Requirements (IVDR)Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class.
- GSPRsGeneral Safety and Performance RequirementsAnnex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
- GUDIDGlobal Unique Device Identification DatabaseFDA database holding key device identification information for all UDIs.
H14 acronyms
- H-ISACHealth Information Sharing and Analysis CenterMember-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector.
- HCPCSHCPCS CodesCMS-maintained codes for products, supplies, and services not in CPT.
- HDEHumanitarian Device ExemptionFDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year.
- HEORHealth Economics and Outcomes ResearchResearch discipline that generates economic, clinical, and patient-reported evidence to support payer access, HTA submissions, and value demonstration.
- HFEHuman Factors EngineeringEngineering discipline focused on safe and effective device use by intended users.
- HHEHealth Hazard EvaluationStructured assessment of patient/user risk used to support recall classification and field-action decisions.
- HICPHealth Industry Cybersecurity PracticesConsensus cybersecurity practices for healthcare published under HHS Section 405(d), the recognized 'reasonable practices' safe-harbor reference.
- HIPAAHIPAAU.S. federal law governing the privacy and security of protected health information.
- HITECHHITECH ActU.S. law that strengthened HIPAA enforcement and introduced breach-notification requirements.
- HITRUSTHITRUST CSFHealthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set.
- HPH-CPGHealthcare and Public Health Cybersecurity Performance GoalsHHS's sector-specific list of essential and enhanced cybersecurity goals for healthcare, derived from HICP and the NIST CSF.
- HRoTHardware Root of TrustA tamper-resistant hardware element (TPM, secure element, or fused boot ROM) that provides the foundational, unforgeable trust anchor for secure boot, attestation, and key storage.
- HSCC JSPHSCC Joint Security PlanAn industry-developed reference framework from the Healthcare Sector Coordinating Council for end-to-end MedTech cybersecurity.
- HTAHealth Technology AssessmentSystematic evaluation of clinical and economic value of a health technology.
I17 acronyms
- IBInvestigator BrochureCompilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.
- ICERIncremental Cost-Effectiveness RatioCost per additional unit of health outcome (often QALY) versus comparator.
- ICSMAICS Medical AdvisoryCISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN.
- IDEInvestigational Device ExemptionFDA authorization to use an investigational device in a clinical study.
- IDNIntegrated Delivery NetworkNetwork of healthcare facilities under common ownership or affiliation.
- IFUInstructions for UseInformation supplied by the manufacturer to inform the user of safe use of a device.
- IFU (statement)Indications for UseDescription of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
- IITInvestigator-Initiated TrialA clinical trial where an individual investigator (typically academic), not the device or drug manufacturer, holds the regulatory sponsor role and is responsible for IRB, IDE/IND, and conduct.
- IPOInitial Public OfferingFirst sale of a company's stock to public investors via a registered SEC offering, typically on NYSE or Nasdaq.
- IPPSInpatient Prospective Payment SystemMedicare's payment system for inpatient hospital stays.
- IRBInstitutional Review BoardBoard that reviews and approves human-subjects research at an institution.
- ISAOInformation Sharing and Analysis OrganizationA self-organized entity, authorized under the Cybersecurity Act of 2015, that gathers, analyzes, and shares cybersecurity threat information among members, including in the health sector.
- ISO 27001ISO/IEC 27001International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers.
- ITT / PPIntent-to-Treat vs Per-ProtocolTwo analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol.
- IVDIn Vitro Diagnostics (Segment)Tests performed on biological samples outside the body to inform diagnosis or treatment.
- IVDIn Vitro DiagnosticsTests performed on biological samples outside the body.
- IVDREU In Vitro Diagnostic RegulationRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
J1 acronym
K2 acronyms
L4 acronyms
- LDTLaboratory-Developed TestIVD designed, manufactured, and used within a single CLIA laboratory.
- LoD / LoQLimit of Detection / Limit of QuantitationLowest analyte concentrations an assay can reliably detect (LoD) or quantify (LoQ).
- LP / GPLimited Partner / General PartnerThe two principal roles in a venture capital fund: LPs provide capital, GPs manage the fund and make investment decisions.
- LTFLetter to FileInternal documentation justifying that a device change does not require a new 510(k) submission.
M20 acronyms
- M&AMergers and AcquisitionsTransactions in which one company acquires or combines with another, the dominant MedTech exit path, typically a strategic acquisition by an established player.
- MACMedicare Administrative ContractorPrivate contractors that process Medicare Part A/B and DME claims and issue Local Coverage Determinations within their jurisdictions.
- MAFDevice Master FileConfidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them.
- MCIDMinimal Clinically Important DifferenceSmallest change in a measurement that patients perceive as clinically meaningful.
- MDCGMedical Device Coordination Group GuidanceGuidance documents from the EU-level expert group that interpret MDR/IVDR requirements.
- MDDSMedical Device Data SystemHardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments.
- MDICMedical Device Innovation ConsortiumPublic-private partnership to advance medical device regulatory science.
- MDLHealth Canada Medical Device LicenceAuthorization required to import or sell Class II, III, or IV medical devices in Canada.
- MDREU Medical Device RegulationRegulation (EU) 2017/745 governing medical devices in the European Union.
- MDRMedical Device Reporting (FDA)FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
- MDS2Manufacturer Disclosure Statement for Medical Device SecurityA standardized form by which device manufacturers disclose security characteristics to healthcare delivery organizations.
- MDSAPMedical Device Single Audit ProgramSingle audit of a manufacturer's QMS satisfying multiple participating regulators.
- MDUFAMedical Device User Fee AmendmentsStatutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years.
- MFDSMinistry of Food and Drug Safety (Korea)South Korea's regulator for foods, drugs, cosmetics, and medical devices.
- MHRA / UKCAMHRA / UKCA MarkingUK regulator and post-Brexit conformity marking for medical devices in Great Britain.
- MIRManufacturer Incident ReportStandardized EU vigilance report submitted to competent authorities via EUDAMED.
- MLOpsMLOps for Medical DevicesThe set of practices and tooling for deploying, monitoring, retraining, and governing machine learning models in regulated medical device software environments.
- MPFSMedicare Physician Fee ScheduleMedicare's payment system for physician professional services.
- MRP / ERPMRP and ERP SystemsMaterial Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain.
- MS-DRGMS-DRGMedicare's inpatient hospital payment classification system.
N8 acronyms
- NBNotified BodyEU-designated organization that assesses conformity of medical devices under MDR and IVDR.
- NCD / LCDNational and Local Coverage DeterminationsMedicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
- NCRNonconformance (NCR)Failure of a product, process, or system to meet specified requirements.
- NIST 800-53/171NIST SP 800-53 / 800-171Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts.
- NIST CSFNIST Cybersecurity FrameworkA risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs.
- NIST IR 8473NIST IR 8473, Cybersecurity Framework Profile for HPHNIST's Cybersecurity Framework profile tailored to the Healthcare and Public Health sector, translates NIST CSF outcomes into HPH-specific subcategories and references.
- NMPANational Medical Products AdministrationChina's regulatory authority for drugs, medical devices, and cosmetics.
- NTAPNew Technology Add-On PaymentSupplemental Medicare payment for inpatient use of qualifying new technologies.
O2 acronyms
P15 acronyms
- PAIPre-Approval InspectionFDA inspection of a manufacturing facility prior to PMA approval.
- PAMAProtecting Access to Medicare ActLaw that revised Medicare pricing for clinical lab services.
- PCCPPredetermined Change Control PlanFDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
- PFMEA / DFMEAProcess FMEA vs Design FMEATwo FMEA flavors: DFMEA analyzes design failure modes; PFMEA analyzes manufacturing process failure modes.
- PGxPharmacogenomicsThe study of how genetic variation affects an individual's response to drugs, used to guide dosing, drug selection, and companion diagnostic development.
- PLAProprietary Laboratory Analyses CodesAMA CPT code subset that uniquely identifies a single proprietary clinical lab test (LDT or IVD) for pricing and tracking.
- PMAPremarket ApprovalFDA's most stringent device marketing application, required for high-risk Class III devices.
- PMCFPost-Market Clinical Follow-upProactive collection of clinical data on a CE-marked device to confirm safety and performance.
- PMDAPharmaceuticals and Medical Devices AgencyJapan's regulatory authority for medical devices, drugs, and regenerative medicine.
- PMPFPost-Market Performance Follow-upThe IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.
- PMPFPost-Market Performance Follow-Up (IVDR)Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.
- PMSPost-Market SurveillanceActivities to monitor device safety and performance after market release.
- POCPoint-of-Care DiagnosticsDiagnostic tests performed near the patient, outside a central lab.
- PRRCPerson Responsible for Regulatory ComplianceNamed individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.
- PSURPeriodic Safety Update ReportPeriodic EU MDR/IVDR report summarizing post-market surveillance findings.
Q6 acronyms
- Q-SubPre-Submission MeetingFormal FDA feedback request prior to a marketing or IDE submission.
- Q-Sub / Pre-SubQ-Submission (Pre-Submission)Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
- QALYQuality-Adjusted Life YearOutcome metric combining length and quality of life used in HTA.
- QMSQuality Management SystemThe organizational structure, processes, and resources a manufacturer implements to consistently design, manufacture, and support devices meeting regulatory and quality requirements.
- QMSRQuality Management System RegulationFDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
- QSR / 21 CFR 820Quality System RegulationFDA's current good manufacturing practice (cGMP) requirements for medical devices.
R11 acronyms
- RACRecovery Audit ContractorCMS contractor that audits Medicare claims for improper payments.
- RAPSRegulatory Affairs Professionals SocietyGlobal professional society for regulatory affairs across health-product industries.
- RBMRisk-Based MonitoringMonitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification.
- RFDRequest for DesignationFormal mechanism to obtain a binding FDA decision on which Center will regulate a product.
- RMFRisk Management FileSet of records and outputs from the ISO 14971 risk management process.
- RPMWearables and Remote Patient MonitoringConnected devices that capture physiologic data outside traditional clinical settings.
- RPMRemote Patient MonitoringDevices and services that capture patient data outside clinical settings.
- RTARefuse to AcceptFDA administrative decision that a submission is incomplete and won't be substantively reviewed.
- RTA (cyber)Refuse to Accept (Cybersecurity)FDA's authority to reject a premarket submission outright when required cybersecurity content is missing.
- RWDReal-World DataData relating to patient health status or care delivery routinely collected from sources other than traditional clinical trials, the inputs from which Real-World Evidence is derived.
- RWEReal-World EvidenceClinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
S22 acronyms
- SAESerious Adverse EventAdverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly.
- SAFESimple Agreement for Future EquityConvertible instrument that converts to equity at a future priced round.
- SaMDSoftware as a Medical DeviceSoftware intended for medical purposes that performs without being part of a hardware device.
- SBIR/STTRSBIR / STTR GrantsU.S. federal small-business R&D grants from agencies including NIH and DoD.
- SBOMSoftware Bill of MaterialsA machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.
- SDVSource Data VerificationProcess of comparing data in case report forms against original source records.
- SESubstantial EquivalenceThe legal standard a 510(k) device must meet versus a predicate.
- Section 522Section 522 Postmarket SurveillanceFDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.
- SFDASaudi Food and Drug AuthoritySaudi Arabian medical device regulator; central authority for the GCC reliance pathway.
- SiMDSoftware in a Medical DeviceSoftware embedded in or required to operate a hardware medical device.
- SLSASupply-chain Levels for Software ArtifactsOpenSSF framework defining progressive levels of build-system integrity for software supply chain security, focused on tamper-resistance of the build.
- SOUPSoftware of Unknown ProvenanceSoftware not developed for medical device use, or lacking adequate development records, incorporated into a device.
- SPACSpecial Purpose Acquisition CompanyA publicly traded shell company formed to raise capital through an IPO with the sole purpose of acquiring or merging with a private operating company.
- SPDFSecure Product Development FrameworkA documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
- SPDXSPDXAn open SBOM and license-data format published as ISO/IEC 5962:2021.
- Special 510(k)Special 510(k)Streamlined 510(k) for modifications to a manufacturer's own legally marketed device.
- SSCPSummary of Safety and Clinical PerformancePublic-facing summary required for high-risk and implantable devices under EU MDR.
- SSDFSecure Software Development FrameworkNIST SP 800-218, a framework of secure software development practices that is referenced by EO 14028 and increasingly by medical device guidance.
- SSPSummary of Safety and Performance (IVDR)Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED.
- STePSafer Technologies ProgramFDA program for devices addressing less serious conditions but offering meaningful safety improvements.
- STRIDESTRIDE Threat ModelA six-category framework for enumerating threats: Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, Elevation of privilege.
- SUDSingle-Use DeviceA device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.
T8 acronyms
- TCETTransitional Coverage for Emerging TechnologiesCMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices.
- TGATherapeutic Goods AdministrationAustralia's regulator for therapeutic goods including medical devices and IVDs.
- TIR45AAMI TIR45AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle.
- TIR97AAMI TIR97AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
- TMC InnovationTexas Medical Center InnovationHouston-based academic MedTech and digital health accelerator and incubator.
- TMFTrial Master FileThe collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements.
- TPLCTotal Product LifecycleFDA framework integrating premarket and post-market oversight across a device's life.
- TPTTransitional Pass-Through PaymentSupplemental outpatient payment for new device technologies.
U4 acronyms
- UADEUnanticipated Adverse Device EffectAny serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines.
- UDIUnique Device IdentificationSystem for adequate identification of medical devices through distribution and use.
- UKRPUK Responsible PersonUK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market.
- URRAUse-Related Risk AnalysisAnalysis of use scenarios to identify potential use errors and their consequences.
V5 acronyms
- V&VVerification & ValidationConfirming design outputs meet inputs (V) and that devices meet user needs (V).
- VACValue Analysis CommitteeHospital cross-functional committee that reviews and approves new product purchases.
- VBCValue-Based CarePayment tied to outcomes and total cost of care, not volume of services.
- VEXVulnerability Exploitability eXchangeA machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product.
- VMPValidation Master PlanTop-level document describing the manufacturer's overall approach to qualification and validation activities.