Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
What is the difference between RA & QA?
Quality Assurance focuses on internal systems and execution. Regulatory Affairs manages external approvals and regulatory strategy. Both are essential but distinct in scope and often overlapping in practice, especially in small medical device companies.
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.