February 24, 2023 Health Canada Class IV Device Licence Amendment and Fee Forms For a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed: Class IV Medical Device Licence Amendent Application Form Medical Device Application Fee Form On the Application Form, we can bundle multiple […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
What if I Add an Expiration Date for Risk Reduction?
February 24, 2023 What if I Add an Expiration Date for Risk Reduction? If, to reduce risk, you are adding an expiration date to a medical device model for which previously-marketed units do not have such an expiration date, then, generally speaking, the governing regulatory authorities will reflexively suspect/assert that a recall might be […]
Real-Time or Accelerated Aging?
February 22, 2023 Real-Time or Accelerated Aging? As a general rule in the medical device sector, accelerated aging data is expected to be ultimately backed up with real-time data. Consequently, we still generally need to have real-time data to support whatever (let’s say, a 6-year) shelf life we are targeting. If for example we […]
EU MDR Clinical Evaluation Report (CER) Frequency
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 […]
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 […]