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: Clinical Investigations</h1>
Use of Off-Label Clinical Data in Premarket Submissions
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 […]