FDA’s Unique Device Identifier – Regulatory Requirements for Improving Patient Safety and Postmarket Surveillance

March 11, 2020, at 11 AM Eastern

Presented by Jay Mansour

Unique Device Identifiers (UDI) offer enhanced opportunities to evaluate, monitor and improve future safety of medical device products by tracking products from production through patient use. These identifiers appearing on device labels, packaging, and sometimes directly on the device itself allows for improvements to patient safety, facilitates and modernizes postmarket surveillance as well as provides for product innovation in an industry that is seeing rapid advancement.

While the potential for UDIs is vast, many medical device manufacturers and labelers are unsure how to obtain a UDI number, proper measures to update device listings and how to implement best practice systems for ensuring appropriate data tracking.

Join EAS independent consultant Jay Mansour for a look at UDIs, their potential, some potential challenges and how to ensure your products meet FDA’s labeling requirements including tracking mechanisms for the devices themselves.

About the Presenter

Jay Mansour

EAS independent consultant Jay Mansour is a seasoned Medical Device regulatory consultant with 20+ years of experience. He has successfully filed more than 100 510(k) clearances across many technologies and assists clients with QMS turnkey projects, including personnel training, and CE marking products as well as responding to FDA’s 483 and warning letters. He is an expert in Process Validations (software, sterilization and more).

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