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 […]
<h1 class="entry-title">Category: Regulatory</h1>
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 […]