<h1 class="entry-title">Category: FDA Inspections</h1>

FDA Remote Regulatory Assessment

July 16, 2021 FDA Remote Regulatory Assessment   For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here’s a recap:   FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called […]