Digital therapeutics deliver therapeutic interventions - typically through software - driven by high-quality clinical evidence. Many are regulated as SaMD and cleared through 510(k) or De Novo pathways. In the US, many digital therapeutics reach market through De Novo or 510(k), and some use prescription-only labeling. In the EU they are regulated under the MDR, and Germany's DiGA program offers a route to statutory insurance payment. Payment remains the main challenge, so companies pair randomized trial evidence with real-world engagement and outcomes data.

Why it matters

Reimbursement remains the chief commercial challenge. The PDURS HCPCS framework and select state Medicaid programs have begun establishing payment paths.

Common pitfalls

•Assuming all digital health apps are Digital Therapeutics; DTx requires rigorous clinical evidence and regulatory oversight.
•Underestimating the cybersecurity risks inherent in software-based medical devices, leading to vulnerabilities and potential patient harm.
•Failing to involve clinicians and patients in the development process, resulting in a product with poor usability or limited clinical impact.
•Neglecting to consider data privacy requirements, such as GDPR or HIPAA, when designing data collection and storage mechanisms.
•Ignoring post-market surveillance requirements for SaMD, which are crucial for ongoing safety and performance monitoring.

Sources

DTA Definition · Digital Therapeutics Alliance
AdvaMed - Industry Reports · AdvaMed
MedTech Europe - Facts & Figures · MedTech Europe
Software as a Medical Device (SaMD) · U.S. Food and Drug Administration (FDA)

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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

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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.