Section 524B of the Federal Food, Drug, and Cosmetic Act, added by section 3305 of the Consolidated Appropriations Act of 2023, requires sponsors of "cyber devices" to submit a cybersecurity package as part of any premarket submission (510(k), De Novo, PMA, HDE). A cyber device is defined as one that (1) includes software validated, installed, or authorized by the sponsor; (2) has the ability to connect to the internet; and (3) contains technological characteristics that could be vulnerable to cybersecurity threats. 524B took effect for submissions on or after March 29, 2023, and FDA began Refuse-to-Accept (RTA) enforcement on October 1, 2023.

Why it matters

Before 524B, cybersecurity expectations were guidance-level and inconsistently enforced. Today, missing 524B content is a Refuse-to-Accept basis - the submission never reaches substantive review. Most MedTech teams now treat 524B as the spine of their premarket cybersecurity package and align internal design controls (ISO 13485 / 21 CFR 820.30) and risk management (ISO 14971, AAMI TIR57) to produce the required artifacts as a natural output of the development lifecycle.

Common pitfalls

•Assuming legacy 510(k) predicates exempt the new submission from 524B - they do not.
•Submitting a generic 'cybersecurity plan' without the underlying threat model, SBOM, and architecture views.
•Treating the postmarket vulnerability monitoring plan as boilerplate; FDA expects a real, resourced process.
•Ignoring labeling - 524B requires end-user-facing security information (e.g., MDS2-style disclosures).

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.