Drug delivery devices include prefilled syringes, autoinjectors (e.g., GLP-1 pens), wearable injectors (West, Insulet), implantable pumps, and inhalation devices. Often regulated as combination products via CDER-led review with CDRH consult. Products include infusion pumps, autoinjectors, inhalers and wearable injectors. Many are combination products, where FDA assigns a lead center based on primary mode of action. Human factors testing is critical because use errors can harm patients.

Why it matters

GLP-1 demand has driven massive autoinjector and prefilled-syringe capacity expansion. Combination product CMC and human factors are gating items.

Common pitfalls

•Assuming that drug delivery devices are solely regulated as medical devices overlooks the critical aspect of combination product regulation.
•Neglecting to consider the human factors engineering requirements specific to drug delivery devices can lead to usability issues and regulatory non-compliance.
•Failing to adequately address the Chemistry, Manufacturing, and Controls (CMC) aspects for the drug component of a combination product can cause significant regulatory delays.
•Overlooking post-market surveillance requirements that apply to both the device and drug components of a combination product can result in regulatory sanctions.

Sources

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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.

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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.

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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.