First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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.