US MedTech glossary.

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.

Technical information report on cybersecurity risk management for medical devices. The operational companion to ISO 14971 for security risk.

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.

FDA program providing prioritized review and interactive feedback for devices addressing life-threatening or irreversibly debilitating conditions.

US Cybersecurity & Infrastructure Security Agency advisories specific to medical devices, often coordinated with the manufacturer and FDA.

Protocol document describing the rationale, objectives, design, methodology, and statistical analysis of a device clinical investigation.

NIH registry of publicly and privately supported clinical studies. Required registration for most device trials in the US.

Short-term debt instrument that converts into equity at a later priced round, usually with a discount and/or valuation cap.

CMS mechanism that conditions Medicare coverage on participation in approved clinical studies or registries.

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.

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.

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.

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.

Annual registration of every facility that manufactures, repackages, relabels, or imports devices for the US market. Filed via FURLS.

International ethical and scientific quality standard for designing, conducting, and reporting device clinical investigations. FDA-recognized for IDE studies.

Entity that aggregates purchasing volume to negotiate contracts with vendors on behalf of member health systems. Major access gate for hospital sales.

CMS coding system for products, supplies, and services not included in CPT. Often the path to a billable code for new devices.

International standard for medical device software lifecycle processes. Defines software safety classes A/B/C and required activities per class.

Standard for usability engineering of medical devices. Required evidence for FDA submissions involving user interaction.

Independent ethics committee that reviews and approves human-subject research. Required before enrolling participants in a US clinical study.

Network of facilities and providers under a single ownership offering coordinated care. Primary procurement decision unit for hospital-sold devices.

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.

International standard for medical device quality management systems. Required for CE mark, expected by FDA, and demanded by acquirers.

International standard for application of risk management to medical devices. Maps directly into the design history file and cybersecurity risk register.

Influential clinician whose published work and conference presence shape adoption of new devices in a specialty.

Coverage decision issued by a Medicare Administrative Contractor for its jurisdiction. Often the first foothold for a new technology.

Free FDA program qualifying manufacturers under $100M gross receipts (foreign manufacturers included) for reduced user fees on 510(k), De Novo, and PMA submissions.

Nationwide CMS decision on whether Medicare will cover a particular item or service. Issued through a formal evidence-based process.

Section 524B-required plan describing how the manufacturer will monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits.

Free FDA mechanism for written feedback or a meeting on a planned submission. Highest-leverage de-risking step for any device program.

Most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence, typically from clinical trials.

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.

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.

Clinical evidence derived from real-world data (registries, EHRs, claims). Increasingly accepted by FDA for label expansions and post-approval studies.

FDA's administrative completeness review of a 510(k). A submission that fails RTA is bounced within 15 days without substantive review.

Y Combinator-originated instrument providing rights to future equity without debt features. Common at pre-seed and seed.

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+.

Sister program to SBIR that requires formal collaboration with a non-profit research institution. Same award sizes, different partnership structure.

Machine-readable inventory of software components and dependencies in a device. Required content for cyber-device premarket submissions.

Non-binding outline of the principal terms of a financing. The economics and control provisions here drive every subsequent legal doc.

Structured analysis of assets, attackers, attack surfaces, and mitigations. Required artifact in FDA premarket cybersecurity packages.

CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices, paired with evidence development.

Standardized identifier carried on device labels and packaging. Required by FDA for US traceability and recall response.

US-resident individual or business designated by every foreign establishment as FDA's communication channel. Required for FDA registration of foreign manufacturers.

Hospital committee evaluating clinical, economic, and operational value of new technologies before purchasing approval.