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 […]
<h1 class="entry-title">Category: Off-Label Use</h1>
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 […]