February 21, 2023 EU MDR Clinical Evaluation Report (CER) Frequency The EU MDR doesn’t prescribe the frequency at which CERs are to be updated. Modeling this, the MDCG (2020-13) has left manufacturers the liberty to, “…Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
Recall Classification: EU MDR / IVDR
February 20, 2023 Recall Classification: EU MDR / IVDR Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ (e.g., U.S. FDA, Health Canada) defined recall classification tiers are not a clear paradigm of the EU MDR/IVDR (yet the future finalization of the EUDAMED database might […]
Recall Classification: U.S. FDA
February 20, 2023 Recall Classification: U.S. FDA For the U.S. FDA, a risk-based approach is required for categorizing a recall; for planning and implementing a recall (e.g., to assure proper recall depth and effectiveness); for resolving the issues that caused the recall; for writing the recall notification, etc., etc. First, a proposed remedial […]
Marketing for Off-Label Use
February 20, 2023 Marketing for Off-Label Use In a nutshell, ALL of a manufacturer’s advertising/promotional statements must be within the boundaries established by the FDA-cleared/approved intended use and indications. Consequently, if a manufacturer makes claims that the subject device has been tested for, or can be used for, features not directly within the boundaries […]
Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary
February 20, 2023 Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary In a nutshell, if a foreign sponsor/owner of a U.S. FDA 510(k) clearance wants to transfer/relinquish ownership and control over to its U.S. subsidiary (or any other party), then such a business/regulatory model can have regulatory merit and, if properly configured/managed, can generally work […]
Recall Initiation in the U.S.
February 17, 2023 Recall Initiation in the U.S. In most cases, FIRMS initiate recalls rather than FDA: If U.S. recall trigger criteria are met, then FDA generally requires that FIRMS initiate recalls. FDA’s corresponding regulation is called “Firm-initiated recall” and is located at 21 CFR §7.46. See also FDA’s corresponding recent guidance document, […]
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
January 26, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? The most succinct way I’ve seen FDA correlate 21 CFR Part 806 with 21 CFR Part 7 is by stating that Part 806 reports of corrections and removals are required for Part 7 Class I and Class II recalls, yet […]
EU eIFU Regulation: Broader Than Many Think
March 22, 2022 EU eIFU Regulation: Broader Than Many Think Everyone seems to know that Europe’s Regulation (EU) 2021/2026 covers requirements for when eIFU are provided instead of paper IFU. But did you know that the Commission also demands a certain level of conformity with that Regulation also for when eIFU is provided in […]
Standards Aren’t Required, but are Recommended, to Show European Conformity
September 28, 2021 Standards Aren’t Required, but are Recommended, to Show European Conformity You may have heard a rumor that conformity with harmonized standards or other non-harmonized standards is mandatory when showing conformity with the IVDD, MDD, IVDR, or MDR. But that is not the intent of these European Directives and Regulations. Instead, Europe […]
Intended Use vs. Indications For Use: What’s the Difference?
August 5, 2021 Intended Use vs. Indications For Use: What’s the Difference? Successful premarket regulatory strategy and authorizations weigh heavily on proper understanding between the term “Intended Use” as distinguished from “Indications for Use”. That said, it can be difficult to find clearly defined explanations of these terms. For the U.S. FDA jurisdiction, I […]