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 […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
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 […]
Health Canada Class IV Device Licence Amendment and Fee Forms
February 24, 2023 Health Canada Class IV Device Licence Amendment and Fee Forms For a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed: Class IV Medical Device Licence Amendent Application Form Medical Device Application Fee Form On the Application Form, we can bundle multiple […]
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 […]
Real-Time or Accelerated Aging?
February 22, 2023 Real-Time or Accelerated Aging? As a general rule in the medical device sector, accelerated aging data is expected to be ultimately backed up with real-time data. Consequently, we still generally need to have real-time data to support whatever (let’s say, a 6-year) shelf life we are targeting. If for example we […]