FDA 510(k) Submissions

What We Do

A successful 510(k) starts long before submission. We help you define your regulatory strategy, select the right predicate, and build a submission package that reviewers can easily approve.

• Regulatory Strategy: Predicate device selection and substantial equivalence arguments.
• Testing Plans: Guidance on verification and validation testing required for your device code.
• eSTAR Preparation: Complete formatting and population of the FDA's eSTAR template.
• RTA & AI Request Support: Rapid response to Refuse to Accept (RTA) and Additional Information (AI) requests.