fda-consultant-specialist

name	fda-consultant-specialist
description	Manage — FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use
executor	HYBRID
skill_id	business.ra-qm-team.fda-consultant-specialist
status	ADOPTED
security	{"level":"high","pii":false,"approval_required":true}
anchors	["business","compliance","security","design"]
tier	2
input_schema	[{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}]
output_schema	[{"name":"plan","type":"string","description":"Strategic plan or design document"},{"name":"next_steps","type":"array","description":"List of recommended next steps"}]

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
• 510(k) Submission Process
• QSR Compliance
• HIPAA for Medical Devices
• Device Cybersecurity
• Resources

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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+

Pre-Submission Strategy

1. Identify product code and classification
2. Search 510(k) database for predicates
3. Assess substantial equivalence feasibility
4. Prepare Q-Sub questions for FDA
5. Schedule Pre-Sub meeting if needed

Reference: See fda_submission_guide.md for pathway decision matrices and submission requirements.

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510(k) Submission Process