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By - Glen Feye

3D Printing Medical Device Manufacturing= Additive Manufacturing

Does your firm use 3D printing and UV Curing systems to manufacture medical devices..then you must validate these systems based on the new implemented Final FDA Guidance Document-“Technical Considerations for Additive Manufactured Medical Devices.” On December 5, 2017,  FDA issued the final version of the guidance, “Technical Considerations for Additive Manufactured Medical Devices.”  Additive manufacturing (AM), the broad category of

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By - Glen Feye

FDA Issues New Import Data Requirements

One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015. To help meet that challenge in a way that benefits both government and the

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By - Glen Feye

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 devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices

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By - Glen Feye

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 from the Food and Drug Administration (FDA) regarding potential or planned 1) Medical device Investigational Device Exemption (IDE) applications, 2)  Premarket Approval (PMA) applications, 3) Humanitarian Device Exemption (HDE) applications, 4) De novo Petitions

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By - Glen Feye

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 questioned by FDA and receive a “Notice of FDA Action” contact your US Agent and you may need a FDA Compliance Consultant . If your shipment is non compliant- expect  

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