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.

Meditrial offers digital solutions to generate RWE in clinical trials. Contact us today to learn how we can empower your clinical trial!


Meditirial’s Catchtrial ePRO is compliant, secure and intuitive solution to track complete patient data. It includes user-friendly Forms builder interface with easy data saving options. Catchtrial ePro is fully integrated with eDiary for automated daily, weekly and monthly patient data capture and with EDC for a real-time desktop access of the patient-reported data.

Meditrial’s Catchtrial electronic Patient-Reported Outcomes (ePRO) app facilitates better interaction between the patient, investigator and Sponsor by analyzing the status of patient’s health directly received from patient.

Find out more about our digital solutions!

For more details, please see the document from the FDA.

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