<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>

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 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) 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 […]

What if I Add an Expiration Date for Risk Reduction?

February 24, 2023 What if I Add an Expiration Date for Risk Reduction?   If, to reduce risk, you are adding an expiration date to a medical device model for which previously-marketed units do not have such an expiration date, then, generally speaking, the governing regulatory authorities will reflexively suspect/assert that a recall might be […]