April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
<h1 class="entry-title">Category: FDA</h1>
External Documents Kept on an Externally-Controlled Server
April 21, 2023 External Documents Kept on an Externally-Controlled Server I know of no regulations or standards specifically demanding an “internal” copy of standards or country regulations. Instead, the logistics of this are generally left to our discretion. I elaborate further below. Let’s start with ISO 13485 / EN ISO 13485 (as amended […]
UDI for IVD Devices Used In-House: Part 3
April 13, 2023 UDI for IVD Devices Used In-House: Part 3 For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance. But I’m thinking that such […]
Use of Off-Label Clinical Data in Premarket Submissions
April 13, 2023 Use of Off-Label Clinical Data in Premarket Submissions The supporting clinical data for a U.S. 510(k) notification (or other U.S. premarket submission) must generally meet FDA’s standard for “valid scientific evidence”. Specifically, that means (21 CFR 860.7) evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched […]
UDI for IVD Devices Used In-House: Part 2
April 13, 2023 UDI for IVD Devices Used In-House: Part 2 Once the reagent kit components (i.e., essential parts of the finished IVD device) of an IVD are sent to the healthcare facility for clinical use, then the finished IVD is in commercial distribution (thus triggering the UDI requirements) as I understand it. Also, […]
UDI for IVD Devices Used In-House: Part 1
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, […]
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 […]