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">Category: Labeling</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), […]
Marketing for Off-Label Use
February 20, 2023 Marketing for Off-Label Use In a nutshell, ALL of a manufacturer’s advertising/promotional statements must be within the boundaries established by the FDA-cleared/approved intended use and indications. Consequently, if a manufacturer makes claims that the subject device has been tested for, or can be used for, features not directly within the boundaries […]