2027 Healthcare IT Manufacturing 
FDA Law
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.
FDA Law
JUNE 14, 2023
Shuren stated that some of the manufacturers of these devices have already experienced more interactions in the past few weeks than they otherwise would have over the entire development course of their devices. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).
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