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 […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
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, […]
Design Plans: Clearly Identify Design Team Members/Contributors
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 […]
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 […]