FDA Regulatory Consulting
From 510(k) submission through FDA clearance — ADB Consulting & CRO Inc. provides experienced, practitioner-led regulatory support for device companies that need to get it right the first time.
End-to-end preparation, predicate strategy, and FDA response management
Pre-Sub strategy, PCCP development, and De Novo pathway for AI-enabled devices
48-hour CAPA strategy, warning letter remediation, and FDA correspondence
Section 524B requirements, SBOM, threat modeling, premarket documentation
Study design, IDE applications, IRB coordination, and clinical study reports
Quality system design, SOP development, and FDA inspection readiness
Core Services
Comprehensive FDA regulatory services across the full device lifecycle — from classification through post-market surveillance.
Comprehensive submission preparation including predicate analysis, substantial equivalence arguments, testing strategy, and FDA response management.
Explore 510(k) submission preparationPre-Submission strategy, SaMD risk classification, PCCP development, and 510(k) or De Novo pathway for AI-enabled medical devices.
Explore AI/ML SaMD regulatory consultingWarning letter remediation, 48-hour CAPA strategy, FDA response drafting, and ongoing remediation oversight for urgent compliance situations.
Explore FDA 483 emergency responseCybersecurity program development, SBOM creation, threat modeling, and premarket submission documentation for connected medical devices.
Explore Section 524B cybersecurity complianceIDE submission preparation, clinical study design, IRB coordination, data safety monitoring, and clinical trial management.
Explore clinical trials and IDE supportQuality management system design, implementation, and audit readiness. ISO 13485 gap analysis, SOP development, and QMS maintenance.
Explore ISO 13485 QMS consultingPrincipal Consultant
With over 20 years of hands-on FDA regulatory experience, Andre Butler has guided medical device companies — from early-stage startups to established manufacturers — through some of the most complex regulatory challenges in the industry.
How It Works
A structured, transparent process from first call to clearance — you always know where you stand and what comes next.
30-minute call to understand your device, regulatory history, and goals. No cost, no obligation.
Device classification, pathway analysis, predicate selection, and a written regulatory strategy document.
Hands-on preparation of all submission documents, testing coordination, and quality review.
FDA response management, deficiency letters, and final clearance with post-market support available.
Client Results
"Andre navigated us through a complex De Novo submission after our 510(k) was declined. His FDA strategy expertise turned a 9-month delay into a 4-month clearance."
"We received a 483 observation on a Friday afternoon. ADB CRO had a structured CAPA strategy on my desk by Monday morning. Exceptional responsiveness and expertise."
"As an AI/ML startup with no regulatory experience, Andre built our entire SaMD regulatory strategy from the ground up and got us to Pre-Sub in 8 weeks."
Get Started
30 minutes with Andre to assess your regulatory situation and outline the fastest path forward. No obligation.