fda-consultant-specialist

# FDA Consultant Specialist FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements. ## Table of Contents - [FDA Pathway Selection](#fda-pathway-selection) - [510(k) Submission Process](#510k-submission-process) - [QSR Compliance](#qsr-compliance) - [HIPAA for Medical Devices](#hipaa-for-medical-devices) - [Device Cybersecurity](#device-cybersecurity) - [Resources](#resources) --- ## FDA Pathway Selection Determine the appropriate FDA regulatory pathway based on device classification and predicate availability. ### Decision Framework ``` Predicate device exists? ├── YES → Substantially equivalent? │ ├── YES → 510(k) Pathway │ │ ├── No design changes → Abbreviated 510(k) │ │ ├── Manufacturing only → Special 510(k) │ │ └── Design/performance → Traditional 510(k) │ └── NO → PMA or De Novo └── NO → Novel device? ├── Low-to-moderate risk → De Novo └── High risk (Class III) → PMA ``` ### Pathway Comparison | Pathway | When to Use | Timeline | Cost | |---------|-------------|----------|------| | 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 | | 510(k) Special | Manufacturing changes only | 30 days | $21,760 | | 510(k) Abbreviated | Guidance/standard conformance | 30 days | $21,760 | | De Novo | Novel, low-moderate risk | 150 days | $134,676 | | PMA | Class III, no predicate | 180+ days | $425,000+ | #...