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Compliance Dates for UDI Regulatory Requirements

Compliance Dates for UDI Regulatory Requirements

Key compliance dates in the UDI final rule. Compliance Date Requirement September 24, 2014 All Class III devicesThe labels and packages of class III medical devices and...

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Strategic and Effective FDA Pre-Submissions

Strategic and Effective FDA Pre-Submissions

The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA  is to provide a mechanism for applicants through which they can request feedback...

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Addressing FDA Import Alert and “Notice of FDA Action”

Addressing FDA Import Alert and “Notice of FDA Action”

IN LIMBO ON THE BORDER – by Glen Feye FDA is the main gatekeepers for foreign Medical Devices and Drugs imported into the United States. If your shipment is...

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Our Core Team

Our experts are tireless and dedicated to delivering results.

Glen Feye, MS, and CQE

Glen Feye, MS, and CQE

Accurate FDA Consultants President and Founder

Andreas Kern, PhD.

Andreas Kern, PhD.

RA/QA Consultant

Barney King, MD, MBA

Executive Regulatory and Clinical consultant

Carol Cox-McClave MA

Expert Medical Research Process Auditor