Jamie Page | 3D Communications

Jamie Page is a project manager at 3D who combines her experience working at FDA and in industry to help clients prepare for FDA meetings. Before joining 3D, Jamie spent seven years at FDA’s Center for Devices and Radiological Health (CDRH). At CDRH, she held positions as: a Lead Reviewer in the Division of Cardiovascular Devices; a Project Manager in the Division of Neurological and Physical Medicine Devices; and a Designated Federal Officer responsible for coordinating Advisory Committee meetings. Jamie has also been involved in a wide variety of other meetings between FDA and industry including Q-Submissions, Pre-IDEs, Early Feasibility Studies, Expedited Access Programs, and Appeals meetings. Previously, Jamie worked as a Field Clinical Engineer at a start-up medical device company. In this role, she was responsible for device programming and providing technical support during implantation and follow-up visits with patients enrolled in clinical trials. Jamie holds a Master’s of Business Administration, a Bachelor’s degree in Biomedical Engineering, and a Master’s Certificate in Project Management.

Recent Posts

How to Maximize Your Early Interactions with FDA: Perspectives from a Former CDRH Reviewer and Project Manager

Posted by Jamie Page | 3D Communications on September 14, 2017

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This post is brought to you by 3D Communications

As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between a company and its review division really matters – from submission, through a potential Advisory Committee meeting, and beyond. Taking the time to develop a good relationship with FDA, and doing it in a strategic way, can make the difference between a relatively smooth path to approval or a long, frustrating road ahead.

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