April 12, 2023 UDI for IVD Devices Used In-House: Part 1 The U.S. FDA’s and the IVDR’s requirements for UDI aren’t generally contingent on where the subject device is used. Instead, the requirements are contingent on the definition of “medical device” and “in vitro diagnostic medical device” (hereinafter “device” / “devices”). Specifically and plainly, […]
<h1 class="entry-title">Category: FDA</h1>
FDA ESG Digital Certificates
April 10, 2023 FDA ESG Digital Certificates If you are having trouble getting FDA’s ESG portal to work for you because of rejected digital certificates, then there there are at least a couple of alternatives. Specifically, you can seek expert third party assistance getting your digital certificate issues resolved; and/or in the meantime while […]
Is that eQMS platform (such as SharePoint) fit for its purpose?
April 6, 2023 Is that eQMS platform (such as SharePoint) fit for its purpose? I saw a question today wondering whether SharePoint is suitable for maintaining a medical device QMS documents system and record control. In a nutshell, SharePoint (or whatever other eQMS practice is proposed) may or may not be suitable for maintaining […]
Don’t confuse FDA’s Part 11 with FDA’s software validation requirements of §820.70(i)
April 6, 2023 Don’t confuse FDA’s Part 11 with FDA’s software validation requirements of §820.70(i) I oftentimes see narratives that state or imply that FDA’s security and integrity requirements for electronic records and signatures from 21 CFR Part 11 are the same thing as FDA’s quality system or manufacturing “software validation” requirements in 21 […]
FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices
April 5, 2023 FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices A Special 510(k) is intrinsically by definition a 510(k) intended to detail only a 510(k)-cleared device modification(s) rather than to detail the 510(k)-cleared aspects that haven’t been modified. This means that the subject device described in the Special 510(k) cannot be fully characterized […]
FDA Medical Device Repackagers and Relabelers: A Regulatory Overview
April 5, 2023 FDA Medical Device Repackagers and Relabelers: A Regulatory Overview When clients are pondering various business models and wondering if they are “possible”, I often tell them that the regulatory requirements will accommodate pretty much any business model you can invent. So the answer is invariably, “Yes, we can do that”. But […]
FDA PMA Stakeholder Logistics Strategy
April 4, 2023 FDA PMA Stakeholder Logistics Strategy There is much to be addressed with this topic. To help us get pointed in the right direction, here are some key principles: In order to, as some informally say, be “registered in the U.S.”, Class III medical devices requiring Premarket Approval (PMA) require PMA […]
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
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 […]
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 […]