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MedTech Safety

Bio

Erin Keith is a Senior Advisor in the Compliance and Quality Staff in in the Office of Product Quality and Evaluation (OPEQ) at the Center for Devices and Radiological Health (CDRH).  Erin has 30 years of experience with the Food and Drug Administration.  She has previously held numerous management and staff positions throughout CDRH and FDA.  These positions have included the Associate Director for Compliance and Quality in OPEQ, Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) in Office of Device Evaluation (ODE); Deputy Director for the Division of Orthopedic Devices in ODE; the Assistant Country Director for Medical Devices in the India Office; Master Reviewer Compliance Officer in Office of Compliance; and a premarket reviewer in ODE. Erin also represents FDA on international harmonization and standards development activities.  
She obtained her BS in Materials Engineering from Rensselaer Polytechnic Institute and her MS in Materials Science and Engineering from Northwestern University.

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