US: FDA provides examples on real world evidence to support marketing applications for medical devices
The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices.
The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption (HDE), premarket approval (PMA) and more.
Some of the examples applications are based on real-world data collection from national registries; several others are extracted from international and sponsor registries, or a combination of registries and other sources.
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For more details, please see the document from the FDA.
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Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
