March 8, 2023 That Advisory Notice Might be a Recall I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected. The answer is yes, but with great care. Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
EU MDR EUDAMED Accuracy Monitoring – Article 31(5)
March 6, 2023 EU MDR EUDAMED Accuracy Monitoring – Article 31(5) I’m unaware of any EUDAMED functionality at this time that accommodates the Article 31(5) accuracy monitoring. With our clients, we’ve embedded procedures for the periodic accuracy check into a “CE Marking” SOP under Article 10(9), third paragraph, indent (a). Document the periodic accuracy […]
Intended Use vs. Indications For Use: In FDA Submissions and the QMS
March 3, 2023 Intended Use vs. Indications For Use: In FDA Submissions and the QMS I’ll forego a baseline explanation of the difference between “Intended Use” as distinguished from “Indications for Use”, as that was covered in a prior blog entry here. In premarket regulatory submissions or in the Quality Management System (QMS), […]
FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details
March 3, 2023 FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details If multiple changes have been made to the subject device since the prior 510(k), but where only one/some of those changes trigger(s) the need for a new 510(k), and if the aggregate of changes isn’t what’s triggering the need for the new 510(k), then […]
Regulatory is Part of the Design and Design Team: Part 2
March 2, 2023 Regulatory is Part of the Design and Design Team: Part 2 Here are a few more practical examples generally demonstrating that Regulatory can’t be separated from the design team. For example, if a Regulatory staffer compiled the GSPR matrix or an FDA 510(k), then that unfortunately means that staffer wrote […]
Regulatory is Part of the Design and Design Team: Part 1
March 2, 2023 Regulatory is Part of the Design and Design Team: Part 1 ISO 13485 demands that regulatory requirements be included in the required design inputs and outputs along with the corresponding verification (and maybe also validation depending on how a client approaches it). Consequently, the person who authored those regulatory design inputs, […]
FDA 510(k) Predicate Strategy Tip
February 28, 2023 FDA 510(k) Predicate Strategy Tip If your chosen predicate is a prior 510(k)-cleared version of the subject device, then such predicate is generally the best option.
FDA 510(k) Change Strategy: Reprocessing-Focused
February 28, 2023 FDA 510(k) Change Strategy: Reprocessing-Focused If the only thing that has changed is the reprocessing process, then the substance of the new 510(k) can just be focused on the aspects that changed. In other words, no need to restate the device description, software contents, etc., etc., that aren’t affected by the […]
EU MDR PMCF Plan is Needed for Legacy Devices
February 28, 2023 EU MDR PMCF Plan is Needed for Legacy Devices In order for an EU MDR Article 120 “legacy” device (as defined in MDCG 2021-25) MDD certificate to remain valid, certain conditions upon which issuance of that legacy MDD certificate was based shall be maintained regardless of whether devices have yet been […]
What Changes are Allowed for EU MDR Article 120 Legacy Devices?
February 24, 2023 What Changes are Allowed for EU MDR Article 120 Legacy Devices? In general, from purely a legislative EU MDR / MDD perspective, if an EU MDR Article 120(2/3) MDD-certified transitional device has, “…no significant changes in the design and intended purpose…”, then it can be placed on the market or put […]