FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

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.

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Provider Manufacturing IT Medical 64

FDA Law Blog

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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Manufacturing Medical Appointment Patient-Centered 45