December 6, 2023 Responding to a Form FDA 483 One of my favorite types of work is responding to a Form FDA 483. The specific nature and extent of an FDA 483 Observation(s) will influence FDA’s ultimate expectations for the response. Thus, I will always need to see the exact Observation(s) to […]
<h1 class="entry-title">Category: FDA Inspections</h1>
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
FDA UDI for Class 1 510(k)-Exempt Devices
March 10, 2023 FDA UDI for Class 1 510(k)-Exempt Devices I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized. FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject […]
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 […]