FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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.
August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.