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 or view crosswalks by category.
Acronyms with more than one meaning
These letters stand for different things depending on context. Each page explains how to tell them apart.
#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.