January 31, 2024 FDA’s QMSR Final Rule Issued FDA has issued its Final Rule on its new Quality Management System Regulation (QMSR) amending its device current good manufacturing practice (CGMP) requirements of the 1996 Quality System (QS) regulation (21 CFR Part 820) to harmonize and modernize it primarily by incorporating by reference ISO […]
<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 […]