Posts by glen


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 trade community, import entries of products regulated by FDA are...

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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 must be submitted to the GUDID database. § 830.300. A 1-year extension of...

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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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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   “HOLD DESIGNATED” If the appropriate action is not taken in a timely manner- expect...

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