Rapid, reviewer-ready response to FDA cybersecurity deficiencies
You received an FDA cybersecurity deficiency or AI letter
An FDA cybersecurity deficiency letter is not a rejection - it's a 180-day clock. We diagnose what reviewers actually want behind the language of the letter, remediate the underlying gaps, and rebuild the package fast. Senior MedTech experts only, fixed-fee, delivered in days not months.
How we move you through fda response
- Reviewer-intent analysis of every deficiency raised
- Targeted remediation: threat model, SBOM, pen testing, or SPDF gaps
- Reissued evidence package mapped line-by-line to FDA's questions
- Delivered inside your 180-day response window
Services that fit this stage
FDA Deficiency Response
Rapid-response team that resolves FDA cybersecurity deficiencies on the first resubmission - across 510(k), De Novo, PMA, and HDE.
Explore service PremarketFull-Service FDA Premarket Cybersecurity
Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, and PMA submissions - traceable, complete, and aligned with current 524B guidance.
Explore service PremarketMedical Device Threat Modeling
Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.
Explore serviceReady to take on fda response?
Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.