03/17/2026
70% of 510(k) submissions receive a deficiency letter on the first review cycle.
For Human Factors submissions specifically, that number climbs to 90%.
If you're leading a MedTech product through FDA clearance, those aren't the exception. That's the landscape you're operating in.
The instinct when a deficiency letter lands is to start fixing things immediately. In our experience, that's exactly what you should not do. Jumping into remediation before you understand the root cause means you’ll fix the wrong things and face a second deficiency letter. Fix the right things in the wrong order, and you'll waste months. Either way, you're back to square one.
In our latest article, we lay out the five root causes behind the vast majority of Human Factors deficiencies — from poorly structured URRAs to cross-document inconsistencies that undermine an otherwise credible evidence package — and a structured Phase Zero diagnostic framework for understanding precisely where your submission failed before you spend a dollar on remediation.
Whether you're staring at a deficiency notice right now or building the submission that you hope will never get one, this is the diagnostic framework worth adding to your toolbox.
Read the full article here: https://hubs.ly/Q046FTdq0
If your team is navigating a 510(k) deficiency and needs expert eyes on the evidence package, reach out directly. We're here to help you get to clearance — efficiently, and the first time.
