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). A correction is the repair, modification, adjustment, relabeling, destruction or inspection of a device without physically removing it from where it is used; a removal is moving it to another location for those actions. Reports go to the FDA district office and must include specific information listed in 21 CFR 806.10. Actions that are not reportable must still be recorded, with the reason, under 806.20.

Why it matters

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

Common pitfalls

•A common pitfall is misunderstanding the reporting criteria, leading to underreporting or overreporting of events to the FDA.
•Manufacturers often incorrectly assume that all product withdrawals constitute a reportable removal under 21 CFR Part 806.
•Failing to initiate appropriate corrective and preventive actions (CAPA) following a reported correction or removal can lead to repeat issues and regulatory scrutiny.
•Not adequately documenting the decision-making process for whether an action is a correction or removal, or an exempt activity, can result in compliance deficiencies.
•Confusing the reporting requirements of 21 CFR Part 806 with Medical Device Reporting (MDR) under 21 CFR Part 803 can lead to incorrect submissions and timelines.

Sources

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

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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.