All MedTech Terms
456 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 456
340B Drug Pricing Program(340B)
Federal program providing discounted drugs to safety-net providers.
409A Valuation
An independent fair-market-value appraisal of common stock used to set tax-compliant strike prices for employee stock options.
5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
AAMI(AAMI)
Standards body for medical instrumentation; co-publisher of ISO/IEC adoptions.
AAMI SW96
AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
AAMI TIR45(TIR45)
AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle.
AAMI TIR57
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
AAMI TIR97(TIR97)
AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Accreditation Scheme for Conformity Assessment(ASCA)
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Additional Condition for Nonprescription Use(ACNU)
FDA'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.
AdvaMed
U.S. trade association for the medical device and diagnostics industry.
AdvaMed Code of Ethics
Industry code governing interactions between U.S. medical-device companies and healthcare professionals.
AdvaMedDx
Diagnostics-focused division of AdvaMed.
Adversarial Robustness
Resilience of an ML model to inputs deliberately crafted to cause misclassification.
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
Advisory Board
Convening of external experts to advise on strategy or product.
Aesthetic & Energy-Based Devices
Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.
AI Imaging Software
Software that analyzes medical images to triage, detect, or quantify disease.
AI/ML-Enabled Medical Device
Medical device that uses artificial intelligence or machine learning to perform its intended use.