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.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.