The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls
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.
Will LDTs Soon Be Regulated?
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.