Fda Consultant Specialist
Map FDA submission pathways, QSR gaps, HIPAA exposure, and device cybersecurity before you commit engineering to a regulated medical product.
Overview
FDA Consultant Specialist is an agent skill most often used in Validate (also Ship security, Operate compliance) that guides medical device teams through FDA pathway selection, QSR, HIPAA, and cybersecurity planning.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill fda-consultant-specialistWhat is this skill?
- Decision-tree for 510(k), PMA, De Novo, and abbreviated/special/traditional 510(k) variants
- QSR (21 CFR 820) compliance framing for device manufacturers
- HIPAA assessments tailored to connected medical devices
- FDA premarket cybersecurity expectations for software as a medical device
- Structured pathway comparison tables and submission-oriented checklists in SKILL.md
- Covers 510(k), PMA, and De Novo pathway decision framework
- Includes QSR 21 CFR 820, HIPAA, and device cybersecurity sections
Adoption & trust: 726 installs on skills.sh; 17.5k GitHub stars; 3/3 security scanners passed (skills.sh audits).
What problem does it solve?
You are shipping regulated medical software or hardware but cannot confidently pick 510(k), PMA, or De Novo or align QSR, HIPAA, and cybersecurity evidence.
Who is it for?
Indie or small-team founders building SaMD, diagnostics, or connected devices who need structured FDA language before hiring consultants.
Skip if: Non-medical SaaS HIPAA-only checklists, pure clinical trial design, or teams that already have an approved regulatory strategy and locked submission dossier.
When should I use this skill?
User mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
What do I get? / Deliverables
You leave with a documented pathway recommendation, compliance focus areas, and submission-oriented next steps to validate with RA specialists.
- Recommended FDA pathway with rationale
- Compliance focus list (QSR, HIPAA, cybersecurity)
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
Canonical shelf is Validate because pathway choice (510(k) vs PMA vs De Novo) and predicate strategy are go/no-go scope decisions before a full regulated build. Scope subphase covers regulatory feasibility, classification, and what evidence you must plan—not post-launch ops alone.
Where it fits
Decide De Novo versus traditional 510(k) when your predicate match is weak.
Draft QSR-aligned design controls language for your software lifecycle docs.
Align premarket cybersecurity documentation with FDA expectations before submission.
Revisit QSR and post-market themes after a design change triggers a new regulatory path.
How it compares
Regulatory strategy skill for FDA device law—not a generic security audit or HIPAA policy generator for non-device apps.
Common Questions / FAQ
Who is fda-consultant-specialist for?
Solo builders and small medical device or SaMD teams who need FDA pathway and compliance orientation before engineering and documentation work.
When should I use fda-consultant-specialist?
During Validate scope when choosing 510(k)/PMA/De Novo; during Ship security for FDA cybersecurity; and during Operate when maintaining QSR and post-market compliance themes.
Is fda-consultant-specialist safe to install?
Review the Security Audits panel on this Prism page; treat all regulatory output as draft guidance requiring qualified human review before FDA submissions.
SKILL.md
READMESKILL.md - 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+ | ### 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](references/fda_submission_guide.md) for pathway decision matrices and submission requirements. --- ## 510(k) Submission Process ### Workflow ``` Phase 1: Planning ├── Step 1: Identify predicate device(s) ├── Step 2: Compare intended use and technology ├── Step 3: Determine testing requirements └── Checkpoint: SE argument feasible? Phase 2: Preparation ├── Step 4: Complete performance testing ├── Step 5: Prepare device description ├── Step 6: Document SE comparison ├── Step 7: Finalize labeling └── Checkpoint: All required sections complete? Phase 3: Submission ├── Step 8: Assemble submission package ├── Step 9: Submit via eSTAR ├── Step 10: Track acknowledgment └── Checkpoint: Submission accepted? Phase 4: Review ├── Step 11: Monitor review status ├── Step 12: Respond to AI requests ├── Step 13: Receive decision └── Verification: SE letter received? ``` ### Required Sections (21 CFR 807.87) | Section | Content | |---------|---------| | Cover Letter | Submission type, device ID, contact info | | Form 3514 | CDRH premarket review cover sheet | | Device Description | Physical description, principles of operation | | Indications for Use | Form 3881, patient population, use environment | | SE Comparison | Side-by-side comparison with predicate | | Performance Testing | Bench, biocompatibility, electrical safety | | Software Documentation | Level of concern, hazard analysis (IEC 62304) | | Labeling | IFU, package labels, warnings | | 510(k) Summary | Public summary of submission | ### Common RTA Issues | Issue | Prevention | |-------|------------| | Missing user fee | Verify payment before submission | | Incomplete Form 3514 | Review all fields, ensure signature | | No predicate identified | Confirm K-number in FDA database | | Inadequate SE comparison | Address all technological characteri