Thursday, February 1, 2024

FDA Press Release: An Earthquake for FDA Diagnostics Classification?

On January 31, 2024, FDA issued a major press release about its plan to make a large-scale reclassification of diagnostics by risk categories.  Oncology and companion diagnostics are especially implicated.  These will be discussed a lot in the coming week.  

Dr. Shuren, head of CDRH, highlighted this in a speech on February 1 here.  Coverage at Genomeweb here.

Press Release

Coverage at Genomeweb here.  Law article.  Excellent detailed discussion at FOCR.

To paraphrase the main ideas in the press release:

CDRH Announces Intent to Initiate 

the Reclassification Process for Most High Risk IVDs

Jeff Shuren, M.D., J.D., director of the FDA's CDRH, announced plans to reclassify most Class III (high risk) in vitro diagnostic devices (IVDs) to Class II (moderate risk), primarily affecting infectious disease and companion diagnostics. This move allows for easier marketing clearance via the 510(k) notification pathway, fostering more competition and access to these tests. The reclassification is based on establishing special controls to ensure safety and effectiveness. The process began with a September 2023 panel meeting discussing the reclassification of specific infectious disease IVDs. CDRH will continue its risk-based approach for new IVD classifications and periodically review device classifications to ensure appropriate regulatory controls. {GPT4}


AI Corner.

The picture is auto generated from the plain blog text [GPT4/Dalle].