<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>

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 […]

Use of Off-Label Clinical Data in Premarket Submissions

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 […]

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, […]