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Two terms, side by side

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Post-Market

Removal vs Correction (21 CFR 806)

In one line

Reporting categories for field actions: removal physically retrieves the device; correction modifies it in place.

Definition

Manufacturers must report to FDA within 10 working days corrections or removals initiated to reduce health risk or remedy violations. Some actions are exempt (e.g., normal service, market withdrawal not for safety/violation).

Why it matters

806 reporting is separate from recall classification; the two systems intersect but have distinct triggers and timelines.

Sources

21 CFR 806 · eCFR
FDA Recalls - Medical Devices · FDA
EUDAMED Public Site · European Commission

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Post-Market

Medical Device Recall

In one line

Removal or correction of a marketed device that violates FDA law.

Definition

Per 21 CFR Part 7, a recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. Classes I–III reflect risk of serious health consequences.

Why it matters

Most recalls are voluntary. A FDA-mandated recall is rare but possible. Recall data is publicly available.

Sources

FDA Recall Information · FDA
EUDAMED Public Site · European Commission
MDCG Vigilance Guidance · MDCG

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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.