FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. I believe the age range was over 80 hospitalized patients and showed that relatively light level physical activity, often with weights, improved hospital outcomes. I honestly thought probably not for 2026 because it’s virtual. Of course.

IT 64

IT Hospital Screening Patients 64