Health Law Advisor

APRIL 5, 2022

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”

FDA 52

FDA Governance 52

Health Law Advisor

JUNE 1, 2022

Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues. How does FDA define the terms used in this part? Background.

FDA 52

FDA 52

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52