One FDA cybersecurity deficiency typically delays clearance 4-12 weeks. Plug in your numbers to see the real impact on revenue and gross profit.
Best estimate - assumes full launch. Type any whole-dollar amount.
Typical cyber deficiency: 4-12 weeks.
Re-submission cost assumes ~$15K/week of internal + external rework, in line with median MedTech projects we've seen.
We'll send the 7 most common FDA cyber deficiencies and how to prevent each - plus your full ROI model in PDF.
The fastest way to compress your timeline is to fix the deficiency before it happens. Start with the playbook, the readiness check, or the FDA premarket package.
Full SPDF, SBOM, threat model, and pen test - delivered in time for your submission window.
Read FDA premarket cybersecurity servicesAlready received a hold or AI letter? We close cybersecurity deficiencies on the first resubmission.
Read FDA deficiency response5-minute quiz that scores your submission readiness and surfaces the 3 fastest wins.
Read Readiness self-assessmentAAMI SW96 / ISO 14971-aligned threat models reviewers expect to see.
Read Threat modelingSPDX/CycloneDX SBOMs with CVE mapping and end-of-life tracking.
Read FDA-compliant SBOMsStraight answers on FDA Section 524B, SBOMs, pen testing, and timelines.
Read Cybersecurity FAQ