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

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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