FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
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.
64 
Let's personalize your content