April 11, 2023 Design Plans: Clearly Identify Design Team Members/Contributors It’s important to be mindful that ISO TC/210 and FDA expect the design team and its members’ roles to be very clearly defined (i.e., in the design plan). FDA says that, “The importance of defining responsibilities with clarity and without ambiguity should be recognized.” ISO […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></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 […]
EU MDR Basic UDI-DI “essential design and manufacturing characteristics”
April 7, 2023 EU MDR Basic UDI-DI “essential design and manufacturing characteristics” According to the MDCG (2018-1), the Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and […]
Health Canada Medical Device System License Components Sold Separately
April, 6, 2023 Health Canada Medical Device System License Components Sold Separately In general, components of a licensed medical device system can be sold separate from the system on the condition that the label of each component bears the system name. Also, strictly speaking based on Health Canada’s CMDR and guidance terminology and interpretations, […]
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 […]
eIFU MDD & EU MDR Notified Body is Required (as applicable)
April 6, 2023 eIFU MDD & EU MDR Notified Body is Required (as applicable) Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device […]
Don’t Claim Device MR Compatibility Until You’ve Earned It
April 6, 2023 Don’t Claim Device MR Compatibility Until You’ve Earned It For the United States, if a device doesn’t yet have FDA-cleared/approved MR labeling, then it would constitute misbranding (illegal labeling) if a letter or other promotional or instructional information is sent to customers stating that the device is MR safe. In short, […]
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 […]