December 8, 2023 FDA U.S. Agent Services My firm regularly acts as the U.S. Agent for our international clients, so we have lots of experience with that. In general, the foreign firm in its own FURLS registration records must first designate the U.S. Agent. Then the prospective U.S. Agent receives a notification to […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
Responding to a Form FDA 483
December 6, 2023 Responding to a Form FDA 483 One of my favorite types of work is responding to a Form FDA 483. The specific nature and extent of an FDA 483 Observation(s) will influence FDA’s ultimate expectations for the response. Thus, I will always need to see the exact Observation(s) to […]
“Declaration of Conformity” vs. “Certification of Conformity”
April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
External Documents Kept on an Externally-Controlled Server
April 21, 2023 External Documents Kept on an Externally-Controlled Server I know of no regulations or standards specifically demanding an “internal” copy of standards or country regulations. Instead, the logistics of this are generally left to our discretion. I elaborate further below. Let’s start with ISO 13485 / EN ISO 13485 (as amended […]
Declarations of Conformity: U.S. FDA vs. Europe
April 20, 2023 Declarations of Conformity: U.S. FDA vs. Europe I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document. In short, no, the US FDA doesn’t, as a general rule, […]
EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance
April 20, 2023 EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance The assessment of the full QMS via Annex IX includes (among other things) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records […]
Design & Development Includes Regulatory Submissions
April 18, 2023 Design & Development Includes Regulatory Submissions Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation. For example, both the FDA (via the QS […]
EU MDR Accessories: Identification in the IFU
April 14, 2023 EU MDR Accessories: Identification in the IFU In general, for any class of EU MDR device, but especially for a class III device, the IFU must identify any accessories. Specifically, GSPR 23.4(f) requires (among other things) that, where applicable, the IFU shall contain information allowing the healthcare professional to select the […]
EU MDR Device “Lifetime” vs. “Shelf-life”
April 13, 2023 EU MDR Device “Lifetime” vs. “Shelf-life” Distinguishing between “lifetime” vs. “shelf-life” is important to realizing proper EU MDR compliance. For example, regardless of device class, implantable device lifetime needs to be addressed in the information supplied to the patient [except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, […]
UDI for IVD Devices Used In-House: Part 3
April 13, 2023 UDI for IVD Devices Used In-House: Part 3 For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance. But I’m thinking that such […]