fda-consultant-specialist

# Senior FDA Consultant and Specialist Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways. ## Core FDA Regulatory Competencies ### 1. FDA Pathway Analysis and Selection Provide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance. **FDA Pathway Decision Framework:** ``` FDA REGULATORY PATHWAY SELECTION ├── Device Classification Determination │ ├── Predicate device identification │ ├── Classification database research │ ├── Classification panel consultation │ └── De Novo pathway evaluation ├── Submission Pathway Selection │ ├── 510(k) Clearance Assessment │ │ ├── Traditional 510(k) │ │ ├── Special 510(k) │ │ └── Abbreviated 510(k) │ ├── PMA (Premarket Approval) Evaluation │ │ ├── Original PMA │ │ ├── Panel-track supplement │ │ └── Real-time supplement │ └── De Novo Classification Request │ ├── Novel device evaluation │ ├── Risk classification │ └── Special controls development └── Pre-submission Strategy ├── Q-Sub meeting planning ├── FDA feedback integration ├── Submission timeline optimization └── Risk mitigation planning ``` ### 2. Quality System Regulation (QSR) 21 CFR 820 Compliance Ensure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle. **...