An IRB is a committee that reviews biomedical research involving human subjects to ensure their rights and welfare are protected, per 21 CFR Part 56. Under 21 CFR Part 56, an IRB must have at least five members with varied backgrounds, including one non-scientist and one member not affiliated with the institution. It approves, requires changes to, or disapproves studies, reviews informed consent, conducts continuing review, and for device studies decides whether a study is significant or non-significant risk. In the EU the equivalent body is an ethics committee.

Why it matters

Both SR and NSR device studies require IRB approval. Non-U.S. trials use equivalent ethics committees.

Common pitfalls

•Failing to obtain IRB approval before initiating a clinical investigation can lead to regulatory non-compliance and invalidation of study data.
•Misinterpreting the scope of IRB review, assuming it only applies to interventional studies and not to observational studies or studies using existing de-identified data, is a common pitfall.
•Not ensuring that all investigators and research staff have completed appropriate human subjects protection training can result in IRB findings and study delays.
•Neglecting to submit modifications to an approved study protocol to the IRB for review and approval prior to implementation can be a serious regulatory violation.
•Assuming that an IRB approval from one institution is automatically transferable to another without formal review and acceptance by the second institution's IRB is incorrect and can lead to unapproved research activities.

Sources

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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.