April 6, 2023 Don’t Claim Device MR Compatibility Until You’ve Earned It For the United States, if a device doesn’t yet have FDA-cleared/approved MR labeling, then it would constitute misbranding (illegal labeling) if a letter or other promotional or instructional information is sent to customers stating that the device is MR safe. In short, […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices
April 5, 2023 FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices A Special 510(k) is intrinsically by definition a 510(k) intended to detail only a 510(k)-cleared device modification(s) rather than to detail the 510(k)-cleared aspects that haven’t been modified. This means that the subject device described in the Special 510(k) cannot be fully characterized […]
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 […]
FDA PMA Stakeholder Logistics Strategy
April 4, 2023 FDA PMA Stakeholder Logistics Strategy There is much to be addressed with this topic. To help us get pointed in the right direction, here are some key principles: In order to, as some informally say, be “registered in the U.S.”, Class III medical devices requiring Premarket Approval (PMA) require PMA […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2
April 4, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2 Carrying on from the first part of this topic from a couple days ago: Indeed, it is wise to stick with longstanding principles and corresponding normative requirements for medical device QMS documentation. And it’s essential to […]
EU MDR Article 22 Statement vs. Article 19 Declaration
April 3, 2023 EU MDR Article 22 Statement vs. Article 19 Declaration Because an EU MDR Article 22 system or procedure pack Statement of Compatibility (SoC) has a different legislative purpose than the Article 19 Declarations of Conformity (DoC) for the components inside the system or procedure pack, then the SoC and DoC need […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1
April 3, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1 The MDR/IVDR PMS procedures and blank templates for the PMS Plan should be Tier 2 generic quality management system (QMS) documents (i.e., procedures), while the actual PMS Plan should instead be a device-specific Tier 4 QMS […]
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
ChatGPT for Regulatory Documentation
March 30, 2023 ChatGPT for Regulatory Documentation ChatGPT can only be as good as the source information which is publicly available in the electronic information ecosystem. There’s a lot of polluted information in that ecosystem, and it hasn’t necessarily been properly vetted for integrity. I did an informal mock audit of some ChatGPT-generated regulatory […]