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) →Technical information report on cybersecurity risk management for medical devices. The operational companion to ISO 14971 for security risk.
Source: AAMI →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 →FDA program providing prioritized review and interactive feedback for devices addressing life-threatening or irreversibly debilitating conditions.
Source: FDA Breakthrough →US Cybersecurity & Infrastructure Security Agency advisories specific to medical devices, often coordinated with the manufacturer and FDA.
Source: CISA Medical →Protocol document describing the rationale, objectives, design, methodology, and statistical analysis of a device clinical investigation.
Source: ISO 14155 →NIH registry of publicly and privately supported clinical studies. Required registration for most device trials in the US.
Source: ClinicalTrials.gov →Short-term debt instrument that converts into equity at a later priced round, usually with a discount and/or valuation cap.
Source: NVCA →CMS mechanism that conditions Medicare coverage on participation in approved clinical studies or registries.
Source: CMS CED →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 →FD&C Act §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 §524B →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 →Compilation of records describing the design history of a finished device. Demonstrates design was developed per the approved design plan and QSR/13485.
Source: 21 CFR 820.30 →Annual registration of every facility that manufactures, repackages, relabels, or imports devices for the US market. Filed via FURLS.
Source: FDA Reg & Listing →International ethical and scientific quality standard for designing, conducting, and reporting device clinical investigations. FDA-recognized for IDE studies.
Source: ISO 14155 →Entity that aggregates purchasing volume to negotiate contracts with vendors on behalf of member health systems. Major access gate for hospital sales.
Source: HSCA →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 →International standard for medical device software lifecycle processes. Defines software safety classes A/B/C and required activities per class.
Source: IEC 62304 →Standard for usability engineering of medical devices. Required evidence for FDA submissions involving user interaction.
Source: IEC 62366 →Independent ethics committee that reviews and approves human-subject research. Required before enrolling participants in a US clinical study.
Source: FDA IRB →Network of facilities and providers under a single ownership offering coordinated care. Primary procurement decision unit for hospital-sold devices.
Source: AdvaMed →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 →International standard for medical device quality management systems. Required for CE mark, expected by FDA, and demanded by acquirers.
Source: ISO 13485 →International standard for application of risk management to medical devices. Maps directly into the design history file and cybersecurity risk register.
Source: ISO 14971 →Influential clinician whose published work and conference presence shape adoption of new devices in a specialty.
Source: AdvaMed →Coverage decision issued by a Medicare Administrative Contractor for its jurisdiction. Often the first foothold for a new technology.
Source: CMS LCD →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 →Nationwide CMS decision on whether Medicare will cover a particular item or service. Issued through a formal evidence-based process.
Source: CMS NCD →§524B-required plan describing how the manufacturer will monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits.
Source: FDA Cyber Guidance →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 →Most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence, typically from clinical trials.
Source: FDA PMA →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 →FDA's quality system regulation for medical device manufacturers. Being harmonized with ISO 13485 under the Quality Management System Regulation (QMSR), effective Feb 2026.
Source: 21 CFR 820 →Clinical evidence derived from real-world data (registries, EHRs, claims). Increasingly accepted by FDA for label expansions and post-approval studies.
Source: FDA RWE →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 →Y Combinator-originated instrument providing rights to future equity without debt features. Common at pre-seed and seed.
Source: YC SAFE →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 →Sister program to SBIR that requires formal collaboration with a non-profit research institution. Same award sizes, different partnership structure.
Source: NIH STTR →Machine-readable inventory of software components and dependencies in a device. Required content for cyber-device premarket submissions.
Source: FDA Cyber Guidance →Non-binding outline of the principal terms of a financing. The economics and control provisions here drive every subsequent legal doc.
Source: NVCA Templates →Structured analysis of assets, attackers, attack surfaces, and mitigations. Required artifact in FDA premarket cybersecurity packages.
Source: FDA Cyber Guidance →CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices, paired with evidence development.
Source: CMS TCET →Standardized identifier carried on device labels and packaging. Required by FDA for US traceability and recall response.
Source: FDA UDI →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 →Hospital committee evaluating clinical, economic, and operational value of new technologies before purchasing approval.
Source: AHRMM →