January 19, 2024 U.S. FDA 510(k) Clinical Data Requirements I always reminded clients that clinical data may not be required at all for a 510(k) subject device even though clinical data may have been required for the predicate. A pre-sub(s) is generally a good idea and in all parties’ best interest for unusual […]
<h1 class="entry-title">Category: 510(k)</h1>
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, […]
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 […]
FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices
April 5, 2023 FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices A Special 510(k) is intrinsically by definition a 510(k) intended to detail only a 510(k)-cleared device modification(s) rather than to detail the 510(k)-cleared aspects that haven’t been modified. This means that the subject device described in the Special 510(k) cannot be fully characterized […]
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), […]
FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details
March 3, 2023 FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details If multiple changes have been made to the subject device since the prior 510(k), but where only one/some of those changes trigger(s) the need for a new 510(k), and if the aggregate of changes isn’t what’s triggering the need for the new 510(k), then […]
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 […]
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 […]