April 4, 2023 FDA PMA Stakeholder Logistics Strategy There is much to be addressed with this topic. To help us get pointed in the right direction, here are some key principles: In order to, as some informally say, be “registered in the U.S.”, Class III medical devices requiring Premarket Approval (PMA) require PMA […]
<h1 class="entry-title">Category: PMA</h1>
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), […]
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 […]