March 13, 2023 FDA Medical Device “Distributor”, “Private Label Distributor”, and Label Overview For the U.S. medical device jurisdiction, the FDA doesn’t automatically consider the person named on the label to be the manufacturer. This is contrary to other jurisdictions like Europe’s Union and Canada. Accordingly, for the U.S., if the person named on […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
Quality Agreements – Ownership and Format
March 13, 2023 Quality Agreements – Ownership and Format The Quality and/or Regulatory departments need to be the primary authors of the Quality Agreement. Yet the Quality Agreement nonetheless still needs to be corporately/legally executed between the parties. Thus, the signatories should be executive officers in order to assure the Agreement has the necessary […]
DHF Documentation of Design Changes
March 13, 2023 DHF Documentation of Design Changes Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF). Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF. Accordingly, if your system does […]
FDA UDI for Class 1 510(k)-Exempt Devices
March 10, 2023 FDA UDI for Class 1 510(k)-Exempt Devices I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized. FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject […]
Human Factors Data from Animal Studies
March 10, 2023 Human Factors Data from Animal Studies First, as a general rule, my understanding is that the HF Category is intrinsically governed by the nature of the subject device and its intended use rather than the HF study method or results. For example, HF Category 2 devices are expected by the U.S. […]
Health Canada: Licence Amendment vs New Licence Application
March 9, 2023 Health Canada: Licence Amendment vs New Licence Application Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables. Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and […]
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
March 8, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? And as you deliberate on the nature of your proposed field gesture, remember first that 21 CFR Part 806 is not the regulation for categorization, evaluation, or initiation of any recall. Instead, FDA intends Part 806 to be for assuring proper […]
That Advisory Notice Might be a Recall
March 8, 2023 That Advisory Notice Might be a Recall I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected. The answer is yes, but with great care. Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly […]
EU MDR EUDAMED Accuracy Monitoring – Article 31(5)
March 6, 2023 EU MDR EUDAMED Accuracy Monitoring – Article 31(5) I’m unaware of any EUDAMED functionality at this time that accommodates the Article 31(5) accuracy monitoring. With our clients, we’ve embedded procedures for the periodic accuracy check into a “CE Marking” SOP under Article 10(9), third paragraph, indent (a). Document the periodic accuracy […]
Intended Use vs. Indications For Use: In FDA Submissions and the QMS
March 3, 2023 Intended Use vs. Indications For Use: In FDA Submissions and the QMS I’ll forego a baseline explanation of the difference between “Intended Use” as distinguished from “Indications for Use”, as that was covered in a prior blog entry here. In premarket regulatory submissions or in the Quality Management System (QMS), […]