FDA Regulatory Submissions
FDA Regulatory Submissions & Gap Assessments for Medical Device Companies
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.
510(k) & PMA Submissions →
End-to-end preparation, predicate strategy, and FDA response management
AI/ML SaMD Consulting →
Pre-Sub strategy, PCCP development, and De Novo pathway for AI-enabled devices
FDA 483 Emergency Response →
48-hour CAPA strategy, warning letter remediation, and FDA correspondence
Cybersecurity Compliance →
Section 524B requirements, SBOM, threat modeling, premarket documentation
Clinical Trials & IDE →
Study design, IDE applications, IRB coordination, and clinical study reports
ISO 13485 & QMS →
Quality system design, SOP development, and FDA inspection readiness
Core Services
End-to-End Regulatory Support
Comprehensive FDA regulatory services across the full device lifecycle — from classification through post-market surveillance.
Fractional Regulatory Director
Director-level regulatory and quality leadership on retainer. From $3,495/mo.
Explore fractional regulatory director services510(k), PMA & De Novo
Comprehensive submission preparation including predicate analysis, substantial equivalence arguments, testing strategy, and FDA response management.
Explore 510(k) submission preparationAI/ML SaMD Consulting
Pre-Submission strategy, SaMD risk classification, PCCP development, and 510(k) or De Novo pathway for AI-enabled medical devices.
Explore AI/ML SaMD regulatory consultingFDA 483 Emergency Response
Warning letter remediation, 48-hour CAPA strategy, FDA response drafting, and ongoing remediation oversight for urgent compliance situations.
Explore FDA 483 emergency responseCybersecurity (Section 524B)
Cybersecurity program development, SBOM creation, threat modeling, and premarket submission documentation for connected medical devices.
Explore Section 524B cybersecurity complianceClinical Trials & IDE
IDE submission preparation, clinical study design, IRB coordination, data safety monitoring, and clinical trial management.
Explore clinical trials and IDE supportQMS & ISO 13485
Quality management system design, implementation, and audit readiness. ISO 13485 gap analysis, SOP development, and QMS maintenance.
Explore ISO 13485 QMS consultingIND Preparation & Submission
IND authoring, eCTD compilation, and submission under 21 CFR Part 312 — including U.S. Agent services and controlled substance programs. Our first service line built for drug development sponsors.
Explore IND preparation and submissionOrganization
Organized Into Practice Groups
ADB Consulting & CRO Inc. is organized into practice groups by regulatory function and device area — Regulatory Submissions, Clinical & IDE, Quality & Compliance, and Digital Health & Cybersecurity — plus an International Sponsor Program for manufacturers outside the United States. Each group is led by a practice director named in the statement of work and accountable for the engagement through FDA decision.
- 510(k), PMA, De Novo, IDE, and Pre-Sub submissions
- AI/ML SaMD regulatory strategy and PCCP development
- ISO 13485 / QMSR quality systems
- Section 524B cybersecurity compliance for connected devices
- Cardiovascular, surgical/orthopedic/ENT, and digital health device-area depth
How It Works
A Clear Path to FDA Clearance
A structured, transparent process from first call to clearance — you always know where you stand and what comes next.
Discovery Call
30-minute call to understand your device, regulatory history, and goals. No cost, no obligation.
Regulatory Strategy
Device classification, pathway analysis, predicate selection, and a written regulatory strategy document.
Submission Execution
Hands-on preparation of all submission documents, testing coordination, and quality review.
FDA Clearance
FDA response management, deficiency letters, and final clearance with post-market support available.
Client Results
What Clients Say
"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
Book a Free Discovery Call
30 minutes with ADB's regulatory team to assess your regulatory situation and outline the fastest path forward. No obligation.