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

Regulatory Misconduct Allegations

March 23, 2023 Regulatory Misconduct Allegations   Making unsubstantiated claims about one’s device, promoting off-label uses, and selling medical devices with uncleared/unapproved features are examples of what the U.S. FDA calls “regulatory misconduct”.  Specifically, regulatory misconduct is when a medical device manufacturer or other individuals marketing medical devices are doing so in a manner that […]

EU IVDR Accessory Definition Triggered for an Optional Item?

March 22, 2023 EU IVDR Accessory Definition Triggered for an Optional Item?   Per Europe’s IVDR, the definition of accessory for an in vitro diagnostic device’ [Article 2(4)] is definitely not invoked when the potential accessory (e.g., a barcode scanner) is an optional add-on module or peripheral.  Nor is the ‘accessory’ category triggered if the potential […]

Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life

March 22, 2023 Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life   Biological evaluation for reusable devices may reasonably not be focused on “shelf life”. The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device’s lifetime.  Much can be said […]

Nonconforming Expiration Date

March 22, 2023 Nonconforming Expiration Date   In short, if erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then such product can be accepted as-is and left alone.  But if the risk acceptance criteria are exceeded, then corrective […]

Problem Containment Actions for Controlling Regulatory Impact

March 21, 2023 Problem Containment Actions for Controlling Regulatory Impact   Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk.  This reminds me of ISO 13485’s deliberate distinction between […]

EU MDR Notified Body Demanding Use of Harmonized Standards

March 21, 2023   EU MDR Notified Body Demanding Use of Harmonized Standards   Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR.  I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse.  But without seeing the full details […]

EU MDR Classification of Accessories

March 21, 2023   EU MDR Classification of Accessories   Pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.

Shelf Life Isn’t Always Required on Medical Device Labels

March 13, 2023 Shelf Life Isn’t Always Required on Medical Device Labels   FDA’s medical device label regulations at 21 CFR §801.18 include the language, “…Whenever the label of a medical device includes a printed expiration date…”, thereby leaving open the possibility that a medical device label might not include an expiration date.  In alignment […]