With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.