<h1 class="entry-title">Category: Private Label Distributor</h1>

FDA Medical Device “Distributor”, “Private Label Distributor”, and Label Overview

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 […]