fda-consultant-specialist_skill

Overview

This skill provides senior FDA consulting and specialist-level support for medical device companies, covering FDA pathway selection, QSR (21 CFR 820) compliance, HIPAA evaluations, and cybersecurity guidance. I help teams prepare regulatory submissions, design inspection-ready quality systems, and develop market access strategies that align regulatory and commercial goals. Services span pre-submission planning through post-market obligations and ongoing regulatory intelligence.

How this skill works

I assess device classification and recommend the optimal FDA submission pathway (510(k), De Novo, PMA, or combination product routing). I audit quality systems against QSR, design CAPA and documentation controls, and map HIPAA and technical safeguards for PHI. For software and connected devices I integrate cybersecurity risk management, SBOMs, and post-market patching plans. I can also prepare submission artifacts, manage FDA communications, and run mock inspections.

When to use it

• Planning regulatory strategy for a new medical device or SaMD
• Preparing a 510(k), De Novo request, or PMA submission
• Conducting a QSR compliance gap analysis or CAPA remediation
• Evaluating HIPAA risks for devices or associated software handling PHI
• Preparing for FDA inspections or responding to warning letters

Best practices

• Start classification and predicate analysis early to define testing and clinical needs
• Maintain traceable design controls and up-to-date device history records
• Document HIPAA administrative, physical, and technical safeguards with evidentiary artifacts
• Implement a formal cybersecurity risk management lifecycle and SBOM for connected products
• Use mock inspections and management review cycles to verify inspection readiness

Example use cases

• Selecting between traditional 510(k) and De Novo for a novel diagnostic device
• Remediating CAPA and responding to an FDA Form 483 or warning letter
• Designing HIPAA-compliant cloud architecture and business associate agreements
• Preparing IDE and clinical protocols for a PMA clinical study
• Creating an SBOM and vulnerability disclosure process for a networked medical device