--- title: "MedTech Glossary - FDA, CMS, Clinical & Cyber" description: "Plain-English definitions of FDA, CMS, clinical, cyber and funding terms medtech founders hit on day one. Each entry links to the primary source." lang: en json-ld: | { "@context": "https://schema.org", "@type": "DefinedTermSet", "name": "US MedTech Glossary", "url": "https://medtechlaunchguide.com/glossary", "inDefinedTermSet": [ { "@type": "DefinedTerm", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "description": "FDA submission demonstrating that a device is substantially equivalent to a legally marketed predicate device. The most common US clearance pathway for moderate-risk devices.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k" }, { "@type": "DefinedTerm", "name": "De Novo Classification", "description": "Pathway for novel low-to-moderate-risk devices with no valid predicate. Establishes a new classification and can become a predicate for future 510(k)s.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request" }, { "@type": "DefinedTerm", "name": "Premarket Approval", "alternateName": "PMA", "description": "Most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence, typically from clinical trials.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma" }, { "@type": "DefinedTerm", "name": "Pre-Submission", "alternateName": "Pre-Sub / Q-Sub", "description": "Free FDA mechanism for written feedback or a meeting on a planned submission. Highest-leverage de-risking step for any device program.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program" }, { "@type": "DefinedTerm", "name": "Investigational Device Exemption", "alternateName": "IDE", "description": "FDA authorization to use an unapproved device in a clinical study to collect safety and effectiveness data. Required for significant-risk device trials in the US.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide" }, { "@type": "DefinedTerm", "name": "Breakthrough Devices Program", "description": "FDA program providing prioritized review and interactive feedback for devices addressing life-threatening or irreversibly debilitating conditions.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program" }, { "@type": "DefinedTerm", "name": "Unique Device Identifier", "alternateName": "UDI", "description": "Standardized identifier carried on device labels and packaging. Required by FDA for US traceability and recall response.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system" }, { "@type": "DefinedTerm", "name": "US Agent", "description": "US-resident individual or business designated by every foreign establishment as FDA's communication channel. Required for FDA registration of foreign manufacturers.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing" }, { "@type": "DefinedTerm", "name": "FDA Establishment Registration", "description": "Annual registration of every facility that manufactures, repackages, relabels, or imports devices for the US market. Filed via FURLS.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing" }, { "@type": "DefinedTerm", "name": "Refuse to Accept (RTA)", "description": "FDA's administrative completeness review of a 510(k). A submission that fails RTA is bounced within 15 days without substantive review.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks" }, { "@type": "DefinedTerm", "name": "MDUFA Small Business Determination", "alternateName": "SBD", "description": "Free FDA program qualifying manufacturers under $100M gross receipts (foreign manufacturers included) for reduced user fees on 510(k), De Novo, and PMA submissions.", "inDefinedTermSet": "Regulatory", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program" }, { "@type": "DefinedTerm", "name": "ISO 13485", "description": "International standard for medical device quality management systems. Required for CE mark, expected by FDA, and demanded by acquirers.", "inDefinedTermSet": "Quality", "url": "https://www.iso.org/iso-13485-medical-devices.html" }, { "@type": "DefinedTerm", "name": "Quality System Regulation", "alternateName": "QSR / 21 CFR 820", "description": "FDA's quality system rule for device manufacturers. Since 2 Feb 2026 it is the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference in place of the old QSR subparts.", "inDefinedTermSet": "Quality", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820" }, { "@type": "DefinedTerm", "name": "Design History File", "alternateName": "DHF", "description": "Compilation of records showing a finished device was developed per its approved design plan. Under QMSR the old 21 CFR 820.30 design-control section is reserved; the requirements now come from ISO 13485:2016 clause 7.3 as incorporated into Part 820.", "inDefinedTermSet": "Quality", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820" }, { "@type": "DefinedTerm", "name": "ISO 14971", "description": "International standard for application of risk management to medical devices. Maps directly into the design history file and cybersecurity risk register.", "inDefinedTermSet": "Quality", "url": "https://www.iso.org/standard/72704.html" }, { "@type": "DefinedTerm", "name": "IEC 62304", "description": "International standard for medical device software lifecycle processes. Defines software safety classes A/B/C and required activities per class.", "inDefinedTermSet": "Quality", "url": "https://www.iso.org/standard/38421.html" }, { "@type": "DefinedTerm", "name": "IEC 62366", "description": "Standard for usability engineering of medical devices. Required evidence for FDA submissions involving user interaction.", "inDefinedTermSet": "Quality", "url": "https://www.iso.org/standard/63179.html" }, { "@type": "DefinedTerm", "name": "QMSR - Quality Management System Regulation", "description": "FDA's harmonized 21 CFR 820 framework that incorporates ISO 13485:2016 by reference. Effective 2 Feb 2026 - foreign sites are subject to FDA inspection under it.", "inDefinedTermSet": "Quality", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr" }, { "@type": "DefinedTerm", "name": "Institutional Review Board", "alternateName": "IRB", "description": "Independent ethics committee that reviews and approves human-subject research. Required before enrolling participants in a US clinical study.", "inDefinedTermSet": "Clinical", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions" }, { "@type": "DefinedTerm", "name": "Clinical Investigation Plan", "alternateName": "CIP", "description": "Protocol document describing the rationale, objectives, design, methodology, and statistical analysis of a device clinical investigation.", "inDefinedTermSet": "Clinical", "url": "https://www.iso.org/standard/71690.html" }, { "@type": "DefinedTerm", "name": "Real-World Evidence", "alternateName": "RWE", "description": "Clinical evidence derived from real-world data (registries, EHRs, claims). Increasingly accepted by FDA for label expansions and post-approval studies.", "inDefinedTermSet": "Clinical", "url": "https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence" }, { "@type": "DefinedTerm", "name": "ClinicalTrials.gov", "description": "NIH registry of publicly and privately supported clinical studies. Required registration for most device trials in the US.", "inDefinedTermSet": "Clinical", "url": "https://clinicaltrials.gov/" }, { "@type": "DefinedTerm", "name": "Good Clinical Practice", "alternateName": "GCP / ISO 14155", "description": "International ethical and scientific quality standard for designing, conducting, and reporting device clinical investigations. FDA-recognized for IDE studies.", "inDefinedTermSet": "Clinical", "url": "https://www.iso.org/standard/71690.html" }, { "@type": "DefinedTerm", "name": "Acceptance of Foreign Clinical Data", "description": "FDA guidance on when clinical data from outside the US can support a device submission. Foreign data can support a 510(k) but rarely a PMA without US enrollment.", "inDefinedTermSet": "Clinical", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-medical-device-applications-and-submissions-frequently-asked" }, { "@type": "DefinedTerm", "name": "Current Procedural Terminology", "alternateName": "CPT", "description": "AMA-maintained code set used to report medical procedures to payers. Category I codes are required for predictable reimbursement; Category III are temporary tracking codes.", "inDefinedTermSet": "Reimbursement", "url": "https://www.ama-assn.org/practice-management/cpt" }, { "@type": "DefinedTerm", "name": "Healthcare Common Procedure Coding System", "alternateName": "HCPCS", "description": "CMS coding system for products, supplies, and services not included in CPT. Often the path to a billable code for new devices.", "inDefinedTermSet": "Reimbursement", "url": "https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system" }, { "@type": "DefinedTerm", "name": "National Coverage Determination", "alternateName": "NCD", "description": "Nationwide CMS decision on whether Medicare will cover a particular item or service. Issued through a formal evidence-based process.", "inDefinedTermSet": "Reimbursement", "url": "https://www.cms.gov/medicare/coverage/coverage-with-evidence-development" }, { "@type": "DefinedTerm", "name": "Local Coverage Determination", "alternateName": "LCD", "description": "Coverage decision issued by a Medicare Administrative Contractor for its jurisdiction. Often the first foothold for a new technology.", "inDefinedTermSet": "Reimbursement", "url": "https://www.cms.gov/medicare/coverage/determination-process/local" }, { "@type": "DefinedTerm", "name": "Transitional Coverage for Emerging Technologies", "alternateName": "TCET", "description": "CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices, paired with evidence development.", "inDefinedTermSet": "Reimbursement", "url": "https://www.cms.gov/medicare/coverage/coverage-with-evidence-development" }, { "@type": "DefinedTerm", "name": "Coverage with Evidence Development", "alternateName": "CED", "description": "CMS mechanism that conditions Medicare coverage on participation in approved clinical studies or registries.", "inDefinedTermSet": "Reimbursement", "url": "https://www.cms.gov/medicare/coverage/coverage-with-evidence-development" }, { "@type": "DefinedTerm", "name": "Cyber Device", "description": "FD&C Act Section 524B definition: a device that includes software, has the ability to connect to the internet, and contains technological features vulnerable to cybersecurity threats.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity" }, { "@type": "DefinedTerm", "name": "Software Bill of Materials", "alternateName": "SBOM", "description": "Machine-readable inventory of software components and dependencies in a device. Required content for cyber-device premarket submissions.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.fda.gov/media/119933/download" }, { "@type": "DefinedTerm", "name": "Threat Model", "description": "Structured analysis of assets, attackers, attack surfaces, and mitigations. Required artifact in FDA premarket cybersecurity packages.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.fda.gov/media/119933/download" }, { "@type": "DefinedTerm", "name": "Postmarket Cybersecurity Plan", "description": "Section 524B-required plan describing how the manufacturer will monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.fda.gov/media/119933/download" }, { "@type": "DefinedTerm", "name": "AAMI TIR57", "description": "Technical information report on cybersecurity risk management for medical devices. The operational companion to ISO 14971 for security risk.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.aami.org/" }, { "@type": "DefinedTerm", "name": "CISA Medical Advisory", "description": "US Cybersecurity & Infrastructure Security Agency advisories specific to medical devices, often coordinated with the manufacturer and FDA.", "inDefinedTermSet": "Cybersecurity", "url": "https://www.cisa.gov/news-events/ics-advisories" }, { "@type": "DefinedTerm", "name": "Small Business Innovation Research", "alternateName": "SBIR", "description": "US federal non-dilutive grant program for small businesses. NIH is the largest SBIR funder for medical devices, with Phase I/II awards up to $2M+.", "inDefinedTermSet": "Funding", "url": "https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr" }, { "@type": "DefinedTerm", "name": "Small Business Technology Transfer", "alternateName": "STTR", "description": "Sister program to SBIR that requires formal collaboration with a non-profit research institution. Same award sizes, different partnership structure.", "inDefinedTermSet": "Funding", "url": "https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr" }, { "@type": "DefinedTerm", "name": "Convertible Note", "description": "Short-term debt instrument that converts into equity at a later priced round, usually with a discount and/or valuation cap.", "inDefinedTermSet": "Funding", "url": "https://nvca.org/model-legal-documents/" }, { "@type": "DefinedTerm", "name": "Simple Agreement for Future Equity", "alternateName": "SAFE", "description": "Y Combinator-originated instrument providing rights to future equity without debt features. Common at pre-seed and seed.", "inDefinedTermSet": "Funding", "url": "https://www.ycombinator.com/documents" }, { "@type": "DefinedTerm", "name": "Term Sheet", "description": "Non-binding outline of the principal terms of a financing. The economics and control provisions here drive every subsequent legal doc.", "inDefinedTermSet": "Funding", "url": "https://nvca.org/model-legal-documents/" }, { "@type": "DefinedTerm", "name": "Integrated Delivery Network", "alternateName": "IDN", "description": "Network of facilities and providers under a single ownership offering coordinated care. Primary procurement decision unit for hospital-sold devices.", "inDefinedTermSet": "Commercial", "url": "https://www.advamed.org/" }, { "@type": "DefinedTerm", "name": "Group Purchasing Organization", "alternateName": "GPO", "description": "Entity that aggregates purchasing volume to negotiate contracts with vendors on behalf of member health systems. Major access gate for hospital sales.", "inDefinedTermSet": "Commercial", "url": "https://www.supplychainassociation.org/" }, { "@type": "DefinedTerm", "name": "Key Opinion Leader", "alternateName": "KOL", "description": "Influential clinician whose published work and conference presence shape adoption of new devices in a specialty.", "inDefinedTermSet": "Commercial", "url": "https://www.advamed.org/" }, { "@type": "DefinedTerm", "name": "Value Analysis Committee", "alternateName": "VAC", "description": "Hospital committee evaluating clinical, economic, and operational value of new technologies before purchasing approval.", "inDefinedTermSet": "Commercial", "url": "https://www.ahrmm.org/" } ] } --- [Skip to content](#main) [ MedTech Launch Guide Education Hub for Founders ](/) [Roadmap](/roadmap) [Topics](/topics) Tools [Pulse](/pulse)Search ⌘K[Start Here](/start) Search ⌘K Reference · 45 terms # US MedTech _glossary_. Plain-English definitions of the FDA, CMS, clinical, cybersecurity, and funding terminology a founder will hit on day one of bringing a device into the United States. Each entry links to the primary source. This glossary is scoped to US market entry. For the full reference, with 489 sourced terms, category pages, and side-by-side comparisons, see our sister site [MedTech Terms](https://medtechterms.com). Entries below that have a deeper write-up there are marked "Full definition". AllRegulatoryQualityClinicalReimbursementCybersecurityFundingCommercial [#](#letter-#)[A](#letter-A)[B](#letter-B)[C](#letter-C)[D](#letter-D)[F](#letter-F)[G](#letter-G)[H](#letter-H)[I](#letter-I)[K](#letter-K)[L](#letter-L)[M](#letter-M)[N](#letter-N)[P](#letter-P)[Q](#letter-Q)[R](#letter-R)[S](#letter-S)[T](#letter-T)[U](#letter-U)[V](#letter-V) # 1 term ### 510(k) Premarket Notification 510(k) Regulatory FDA submission demonstrating that a device is substantially equivalent to a legally marketed predicate device. The most common US clearance pathway for moderate-risk devices. [Source: FDA 510(k) →](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k)[Full definition ↗](https://medtechterms.com/terms/510k) A 2 terms ### AAMI TIR57 Cybersecurity Technical information report on cybersecurity risk management for medical devices. The operational companion to ISO 14971 for security risk. [Source: AAMI →](https://www.aami.org/)[Full definition ↗](https://medtechterms.com/terms/aami-tir57)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) ### Acceptance of Foreign Clinical Data Clinical FDA guidance on when clinical data from outside the US can support a device submission. Foreign data can support a 510(k) but rarely a PMA without US enrollment. [Source: FDA Guidance →](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-medical-device-applications-and-submissions-frequently-asked) B 1 term ### Breakthrough Devices Program Regulatory FDA program providing prioritized review and interactive feedback for devices addressing life-threatening or irreversibly debilitating conditions. [Source: FDA Breakthrough →](https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program)[Full definition ↗](https://medtechterms.com/terms/breakthrough-device) C 7 terms ### CISA Medical Advisory Cybersecurity US Cybersecurity & Infrastructure Security Agency advisories specific to medical devices, often coordinated with the manufacturer and FDA. [Source: CISA Medical →](https://www.cisa.gov/news-events/ics-advisories)[Full definition ↗](https://medtechterms.com/terms/ics-medical-advisory)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) ### Clinical Investigation Plan CIP Clinical Protocol document describing the rationale, objectives, design, methodology, and statistical analysis of a device clinical investigation. [Source: ISO 14155 →](https://www.iso.org/standard/71690.html)[Full definition ↗](https://medtechterms.com/terms/cip) ### ClinicalTrials.gov Clinical NIH registry of publicly and privately supported clinical studies. Required registration for most device trials in the US. [Source: ClinicalTrials.gov →](https://clinicaltrials.gov/) ### Convertible Note Funding Short-term debt instrument that converts into equity at a later priced round, usually with a discount and/or valuation cap. [Source: NVCA →](https://nvca.org/model-legal-documents/)[Full definition ↗](https://medtechterms.com/terms/convertible-note) ### Coverage with Evidence Development CED Reimbursement CMS mechanism that conditions Medicare coverage on participation in approved clinical studies or registries. [Source: CMS CED →](https://www.cms.gov/medicare/coverage/coverage-with-evidence-development)[Full definition ↗](https://medtechterms.com/terms/ced) ### Current Procedural Terminology CPT Reimbursement AMA-maintained code set used to report medical procedures to payers. Category I codes are required for predictable reimbursement; Category III are temporary tracking codes. [Source: AMA CPT →](https://www.ama-assn.org/practice-management/cpt)[Full definition ↗](https://medtechterms.com/terms/cpt) ### Cyber Device Cybersecurity FD&C Act Section 524B definition: a device that includes software, has the ability to connect to the internet, and contains technological features vulnerable to cybersecurity threats. [Source: FD&C Act Section 524B →](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity)[Full definition ↗](https://medtechterms.com/terms/section-524b)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) D 2 terms ### De Novo Classification Regulatory Pathway for novel low-to-moderate-risk devices with no valid predicate. Establishes a new classification and can become a predicate for future 510(k)s. [Source: FDA De Novo →](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request)[Full definition ↗](https://medtechterms.com/terms/de-novo) ### Design History File DHF Quality Compilation of records showing a finished device was developed per its approved design plan. Under QMSR the old 21 CFR 820.30 design-control section is reserved; the requirements now come from ISO 13485:2016 clause 7.3 as incorporated into Part 820. [Source: 21 CFR 820 (QMSR) →](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)[Full definition ↗](https://medtechterms.com/terms/design-history-file) F 1 term ### FDA Establishment Registration Regulatory Annual registration of every facility that manufactures, repackages, relabels, or imports devices for the US market. Filed via FURLS. [Source: FDA Reg & Listing →](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing) G 2 terms ### Good Clinical Practice GCP / ISO 14155 Clinical International ethical and scientific quality standard for designing, conducting, and reporting device clinical investigations. FDA-recognized for IDE studies. [Source: ISO 14155 →](https://www.iso.org/standard/71690.html)[Full definition ↗](https://medtechterms.com/terms/gcp) ### Group Purchasing Organization GPO Commercial Entity that aggregates purchasing volume to negotiate contracts with vendors on behalf of member health systems. Major access gate for hospital sales. [Source: HSCA →](https://www.supplychainassociation.org/)[Full definition ↗](https://medtechterms.com/terms/gpo) H 1 term ### Healthcare Common Procedure Coding System HCPCS Reimbursement CMS coding system for products, supplies, and services not included in CPT. Often the path to a billable code for new devices. [Source: CMS HCPCS →](https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system)[Full definition ↗](https://medtechterms.com/terms/hcpcs) I 7 terms ### IEC 62304 Quality International standard for medical device software lifecycle processes. Defines software safety classes A/B/C and required activities per class. [Source: IEC 62304 →](https://www.iso.org/standard/38421.html)[Full definition ↗](https://medtechterms.com/terms/iec-62304) ### IEC 62366 Quality Standard for usability engineering of medical devices. Required evidence for FDA submissions involving user interaction. [Source: IEC 62366 →](https://www.iso.org/standard/63179.html)[Full definition ↗](https://medtechterms.com/terms/iec-62366-1) ### Institutional Review Board IRB Clinical Independent ethics committee that reviews and approves human-subject research. Required before enrolling participants in a US clinical study. [Source: FDA IRB →](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions)[Full definition ↗](https://medtechterms.com/terms/irb) ### Integrated Delivery Network IDN Commercial Network of facilities and providers under a single ownership offering coordinated care. Primary procurement decision unit for hospital-sold devices. [Source: AdvaMed →](https://www.advamed.org/)[Full definition ↗](https://medtechterms.com/terms/idn) ### Investigational Device Exemption IDE Regulatory FDA authorization to use an unapproved device in a clinical study to collect safety and effectiveness data. Required for significant-risk device trials in the US. [Source: FDA IDE →](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide)[Full definition ↗](https://medtechterms.com/terms/ide) ### ISO 13485 Quality International standard for medical device quality management systems. Required for CE mark, expected by FDA, and demanded by acquirers. [Source: ISO 13485 →](https://www.iso.org/iso-13485-medical-devices.html)[Full definition ↗](https://medtechterms.com/terms/iso-13485) ### ISO 14971 Quality International standard for application of risk management to medical devices. Maps directly into the design history file and cybersecurity risk register. [Source: ISO 14971 →](https://www.iso.org/standard/72704.html)[Full definition ↗](https://medtechterms.com/terms/iso-14971) K 1 term ### Key Opinion Leader KOL Commercial Influential clinician whose published work and conference presence shape adoption of new devices in a specialty. [Source: AdvaMed →](https://www.advamed.org/)[Full definition ↗](https://medtechterms.com/terms/kol) L 1 term ### Local Coverage Determination LCD Reimbursement Coverage decision issued by a Medicare Administrative Contractor for its jurisdiction. Often the first foothold for a new technology. [Source: CMS LCD →](https://www.cms.gov/medicare/coverage/determination-process/local)[Full definition ↗](https://medtechterms.com/terms/lcd-ncd) M 1 term ### MDUFA Small Business Determination SBD Regulatory Free FDA program qualifying manufacturers under $100M gross receipts (foreign manufacturers included) for reduced user fees on 510(k), De Novo, and PMA submissions. [Source: FDA SBD →](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program) N 1 term ### National Coverage Determination NCD Reimbursement Nationwide CMS decision on whether Medicare will cover a particular item or service. Issued through a formal evidence-based process. [Source: CMS NCD →](https://www.cms.gov/medicare/coverage/coverage-with-evidence-development)[Full definition ↗](https://medtechterms.com/terms/ncd-lcd) P 3 terms ### Postmarket Cybersecurity Plan Cybersecurity Section 524B-required plan describing how the manufacturer will monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits. [Source: FDA Cyber Guidance →](https://www.fda.gov/media/119933/download)[Full definition ↗](https://medtechterms.com/terms/section-524b)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) ### Pre-Submission Pre-Sub / Q-Sub Regulatory Free FDA mechanism for written feedback or a meeting on a planned submission. Highest-leverage de-risking step for any device program. [Source: Q-Sub Program →](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program)[Full definition ↗](https://medtechterms.com/terms/pre-submission) ### Premarket Approval PMA Regulatory Most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence, typically from clinical trials. [Source: FDA PMA →](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma)[Full definition ↗](https://medtechterms.com/terms/pma) Q 2 terms ### QMSR - Quality Management System Regulation Quality FDA's harmonized 21 CFR 820 framework that incorporates ISO 13485:2016 by reference. Effective 2 Feb 2026 - foreign sites are subject to FDA inspection under it. [Source: FDA QMSR →](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr)[Full definition ↗](https://medtechterms.com/terms/qmsr) ### Quality System Regulation QSR / 21 CFR 820 Quality FDA's quality system rule for device manufacturers. Since 2 Feb 2026 it is the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference in place of the old QSR subparts. [Source: 21 CFR 820 →](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)[Full definition ↗](https://medtechterms.com/terms/qsr) R 2 terms ### Real-World Evidence RWE Clinical Clinical evidence derived from real-world data (registries, EHRs, claims). Increasingly accepted by FDA for label expansions and post-approval studies. [Source: FDA RWE →](https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence)[Full definition ↗](https://medtechterms.com/terms/real-world-evidence) ### Refuse to Accept (RTA) Regulatory FDA's administrative completeness review of a 510(k). A submission that fails RTA is bounced within 15 days without substantive review. [Source: FDA RTA →](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks) S 4 terms ### Simple Agreement for Future Equity SAFE Funding Y Combinator-originated instrument providing rights to future equity without debt features. Common at pre-seed and seed. [Source: YC SAFE →](https://www.ycombinator.com/documents)[Full definition ↗](https://medtechterms.com/terms/safe-note) ### Small Business Innovation Research SBIR Funding US federal non-dilutive grant program for small businesses. NIH is the largest SBIR funder for medical devices, with Phase I/II awards up to $2M+. [Source: NIH SBIR →](https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr)[Full definition ↗](https://medtechterms.com/terms/sbir-sttr) ### Small Business Technology Transfer STTR Funding Sister program to SBIR that requires formal collaboration with a non-profit research institution. Same award sizes, different partnership structure. [Source: NIH STTR →](https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr)[Full definition ↗](https://medtechterms.com/terms/sbir-sttr) ### Software Bill of Materials SBOM Cybersecurity Machine-readable inventory of software components and dependencies in a device. Required content for cyber-device premarket submissions. [Source: FDA Cyber Guidance →](https://www.fda.gov/media/119933/download)[Full definition ↗](https://medtechterms.com/terms/sbom)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) T 3 terms ### Term Sheet Funding Non-binding outline of the principal terms of a financing. The economics and control provisions here drive every subsequent legal doc. [Source: NVCA Templates →](https://nvca.org/model-legal-documents/)[Full definition ↗](https://medtechterms.com/terms/term-sheet) ### Threat Model Cybersecurity Structured analysis of assets, attackers, attack surfaces, and mitigations. Required artifact in FDA premarket cybersecurity packages. [Source: FDA Cyber Guidance →](https://www.fda.gov/media/119933/download)[Full definition ↗](https://medtechterms.com/terms/threat-modeling)[Deep dive: Blue Goat Cyber ↗](https://bluegoatcyber.com) ### Transitional Coverage for Emerging Technologies TCET Reimbursement CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices, paired with evidence development. [Source: CMS TCET →](https://www.cms.gov/medicare/coverage/coverage-with-evidence-development)[Full definition ↗](https://medtechterms.com/terms/tcet) U 2 terms ### Unique Device Identifier UDI Regulatory Standardized identifier carried on device labels and packaging. Required by FDA for US traceability and recall response. [Source: FDA UDI →](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system)[Full definition ↗](https://medtechterms.com/terms/udi) ### US Agent Regulatory US-resident individual or business designated by every foreign establishment as FDA's communication channel. Required for FDA registration of foreign manufacturers. [Source: FDA Foreign Mfr →](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing) V 1 term ### Value Analysis Committee VAC Commercial Hospital committee evaluating clinical, economic, and operational value of new technologies before purchasing approval. [Source: AHRMM →](https://www.ahrmm.org/)[Full definition ↗](https://medtechterms.com/terms/vac) MedTech Launch Guide The independent education hub for medtech innovators bringing devices to the US market - paired with a live pulse of what FDA, CMS, CISA and investors are doing right now. 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