January 2, 2026 FDA QMSR: More than Meets the Eye. Are You Ready? Introduction: FDA’s new Quality Management System Regulation (QMSR) is nearly upon us. The QMSR replaces the current Quality System Regulation (QS Regulation). Specifically, after a generous two-year transitional period, the QMSR becomes effective in just a few weeks on […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
MDSAP QMS Internal Auditing Must Verify Regulatory Compliance
November 24, 2025 MDSAP QMS Internal Auditing Must Verify Regulatory Compliance If an organization performs internal auditing only to its SOPs but not also to check the SOPs’ and the organization’s regulatory compliance, then it would be in violation of MDSAP’s requirements for internal auditing. Such an approach would, upon discovery, result in […]
FDA 483 Responses: How to Avoid a Warning Letter
November 12, 2024 FDA 483 Responses: How to Avoid a Warning Letter A firm’s proper actions in response to receiving a Form FDA 483 (“FDA 483”) is a broad subject that we can do training on for hours or even days. Thus, it may not be possible to cover all of the details […]
FDA’s QMSR Final Rule Issued
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 […]
EU MDR Virtual Importers
January 25, 2024 EU MDR Virtual Importers While I can see potential benefits of voluntarily creating an importer (along with the additional regulatory burden) to add a layer of compliance checks and balances, I strongly advise against the basis being an assertion that end users need regulation because they have, as one person […]
UK and EU End Users Are Not Importers
January 25, 2024 UK and EU End Users Are Not Importers Generally speaking, end users are not considered to be importers. This is the same for the UK and the MDD/MDR alike. For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically […]
Are DoC Updates Required for Software Version Changes?
January 22, 2024 Are DoC Updates Required for Software Version Changes? In general, yes. I explain: Remember that the MDR requires the manufacturer to “continuously update the EU declaration of conformity”. For example, if the Technical Documentation (TD) is different for version 3.0 compared to 3.1 to 3.1.1 to 3.2, then the […]
U.S. FDA 510(k) Clinical Data Requirements
January 19, 2024 U.S. FDA 510(k) Clinical Data Requirements I always reminded clients that clinical data may not be required at all for a 510(k) subject device even though clinical data may have been required for the predicate. A pre-sub(s) is generally a good idea and in all parties’ best interest for unusual […]
Notifying Your European Notified Body About Non-Significant Changes
January 11, 2024 Notifying Your European Notified Body About Non-Significant Changes Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or […]
Difficulty Submitting Part 806 Report via FDA’s ESG Gateway
December 12, 2023 Difficulty Submitting Part 806 Report via FDA’s ESG Gateway If for various reasons you are unable to submit your FDA Part 806 Report of Correction or Removal via FDA’s ESG Gateway, then another option is to have a third party submit your 806 report using the third party’s active ESG […]