<h1 class="entry-title">Category: Medical Devices</h1>

FDA Medical Device Repackagers and Relabelers: A Regulatory Overview

April 5, 2023 FDA Medical Device Repackagers and Relabelers: A Regulatory Overview   When clients are pondering various business models and wondering if they are “possible”, I often tell them that the regulatory requirements will accommodate pretty much any business model you can invent.  So the answer is invariably, “Yes, we can do that”.  But […]

So Many Adverse Event Reporting Terms in Various Jurisdictions

April 4, 2023 So Many Adverse Event Reporting Terms in Various Jurisdictions   I’ve seen companies try to combine multiple jurisdictions’ adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the […]