5 Common FDA 510(k) Mistakes That Lead to Rejection

1. Choosing the Wrong Predicate Device

The foundation of a 510(k) is "Substantial Equivalence" (SE). If you choose a predicate that has different technological characteristics or intended use, your submission is dead on arrival. GreenLight OS helps you map characteristics side-by-side to ensure a match.

2. Inadequate Biocompatibility Testing (ISO 10993)

Many applicants assume "medical grade material" is enough. It is not. You must provide testing data according to ISO 10993 based on the nature and duration of body contact.

3. Software Documentation Gaps

If your device contains software, the FDA requires documentation based on the "Level of Concern" (LOC). Missing cybersecurity documentation is the #1 reason for RTAs in 2024.

4. Inconsistent Intended Use Statements

Your "Indications for Use" statement must match exactly across your labeling, 510(k) summary, and user manual. Even a slight variation can trigger a "New Intended Use" flag.

5. Ignoring Guidance Documents

The FDA publishes specific guidance for many device types (e.g., Pulse Oximeters). Ignoring these specific performance testing requirements ensures a deficiency letter.