Compare

Two terms, side by side

Pick any two terms to see definitions, context, pitfalls, and sources in parallel.

Market Segments

Single-Use Device(SUD)

In one line

A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.

Definition

A Single-Use Device (SUD) is one whose original-equipment manufacturer (OEM) labeling restricts it to a single use or single patient. The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 created a separate regulatory pathway for third-party reprocessors of SUDs: they must obtain their own 510(k) clearance and comply with the same cleaning, sterilization, and functional-equivalence validation as OEMs. SUDs and reprocessed SUDs are a major sustainability and cost-pressure topic in hospital purchasing.

Why it matters

Reprocessed SUDs typically cut device cost 40-60% with no clinical performance difference when properly validated. FDA has cleared reprocessed versions of EP catheters, harmonic scalpels, and orthopedic burrs.

Common pitfalls

•Assuming OEM SUD labeling alone prevents a hospital from using a third-party reprocessor — it does not.
•Ignoring environmental and Joint Commission scrutiny of single-use waste streams.

Sources

FDA — Reprocessing of Single-Use Devices · FDA
FDA Guidance — Reprocessing Medical Devices in Health Care Settings (2015) · FDA
MedTech Dive · MedTech Dive

Open full page

Select term B to compare.

Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.