Regulatory Cost & Timeline Estimation Skill
Purpose
Provide three-point cost and timeline estimates for regulatory submissions based on pathway selections. This is a pure analysis unit that receives pathway data and returns structured cost/timeline estimates.
Input: Pathway selection results (selected pathways per region, device class/grade) Output: Cost breakdown (optimistic/expected/pessimistic), timeline with milestones, traffic light indicator Knowledge Base Date: 2026-01
Cost Estimation Framework
Cost Categories
- •
Consulting Services
- •Regulatory strategy consulting
- •Documentation review and guidance
- •Submission preparation support
- •
Testing & Validation
- •Biocompatibility testing
- •Electrical safety testing
- •Performance testing
- •Sterilization validation (if applicable)
- •Software validation (if applicable)
- •
Regulatory Fees
- •FDA user fees (510(k), PMA, De Novo)
- •MFDS application fees
- •Annual establishment fees
- •
Notified Body Fees (EU only)
- •Initial assessment
- •QMS audit
- •Annual surveillance
- •
Clinical Study Costs (if applicable)
- •IRB fees
- •Patient recruitment
- •Data collection and analysis
- •Clinical study report
Three-Point Cost Estimation
Class I Devices
| Region | Pathway | Optimistic | Expected | Pessimistic | Categories |
|---|---|---|---|---|---|
| FDA | 510(k) Exempt | W5-10M | W10-20M | W20-30M | Consulting 40%, Testing 30%, Fees 30% |
| FDA | 510(k) Required | W15-25M | W25-40M | W40-60M | Consulting 35%, Testing 35%, Fees 30% |
| EU MDR | Self-Declaration | W8-15M | W15-25M | W25-40M | Consulting 45%, Testing 35%, Docs 20% |
| MFDS | Grade 1 Registration | W5-12M | W12-20M | W20-35M | Consulting 40%, Testing 35%, Fees 25% |
Class II / IIa Devices
| Region | Pathway | Optimistic | Expected | Pessimistic | Categories |
|---|---|---|---|---|---|
| FDA | 510(k) | W30-60M | W60-100M | W100-150M | Consulting 30%, Testing 40%, Fees 20%, Docs 10% |
| EU MDR | IIa NB | W40-80M | W80-130M | W130-200M | Consulting 25%, Testing 35%, NB 25%, Docs 15% |
| MFDS | Grade 2 Approval | W30-70M | W70-120M | W120-180M | Consulting 30%, Testing 45%, Fees 15%, Docs 10% |
Class II / IIb Devices
| Region | Pathway | Optimistic | Expected | Pessimistic | Categories |
|---|---|---|---|---|---|
| FDA | De Novo | W80-120M | W120-200M | W200-300M | Consulting 30%, Testing 35%, Special Controls 20%, Fees 15% |
| EU MDR | IIb NB | W70-120M | W120-180M | W180-280M | Consulting 25%, Testing 30%, NB 30%, PMCF 15% |
Class III Devices
| Region | Pathway | Optimistic | Expected | Pessimistic | Categories |
|---|---|---|---|---|---|
| FDA | PMA | W200-400M | W400-800M | W800-1,500M | Consulting 20%, Testing 25%, Clinical 40%, Fees 10%, QMS 5% |
| EU MDR | Class III CI | W180-350M | W350-700M | W700-1,200M | Consulting 20%, Testing 20%, Clinical 35%, NB 20%, QMS 5% |
| MFDS | Grade 4 CT | W150-300M | W300-600M | W600-1,000M | Consulting 20%, Testing 25%, Clinical 40%, Fees 10%, QMS 5% |
Timeline Estimation Framework
Milestone-Based Timeline
510(k) Pathway (FDA Class II)
Phase 1: Preparation
- •Duration: 1-2 months
- •Deliverables: Predicate device identification, Gap analysis, Test protocol development
Phase 2: Testing
- •Duration: 2-4 months
- •Deliverables: Biocompatibility, Electrical safety, Performance testing
Phase 3: Documentation
- •Duration: 1-2 months
- •Deliverables: 510(k) submission package, Substantial equivalence report
Phase 4: Submission & Review
- •Duration: 3-6 months (standard) or 1-3 months (expedited)
- •Deliverables: FDA submission, Deficiency response (if any)
Total Timeline:
- •Optimistic: 3-6 months
- •Expected: 6-9 months
- •Pessimistic: 9-12 months
PMA Pathway (FDA Class III)
Phase 1: IDE Preparation
- •Duration: 2-4 months
- •Deliverables: IDE application, IRB approval
Phase 2: Clinical Study
- •Duration: 12-24 months
- •Deliverables: Patient enrollment, Data collection, Clinical study report
Phase 3: PMA Documentation
- •Duration: 3-6 months
- •Deliverables: PMA submission package, Manufacturing QMS documentation
Phase 4: FDA Review
- •Duration: 6-12 months
- •Deliverables: FDA panel meeting, Deficiency responses, Approval
Total Timeline:
- •Optimistic: 12-18 months
- •Expected: 18-30 months
- •Pessimistic: 30-48 months
EU MDR Class IIa (Notified Body)
Phase 1: Preparation
- •Duration: 1-3 months
- •Deliverables: Notified Body selection, Technical file structure
Phase 2: Testing & CER
- •Duration: 3-6 months
- •Deliverables: Testing, Clinical Evaluation Report, PMSP
Phase 3: Notified Body Assessment
- •Duration: 2-4 months
- •Deliverables: Technical file submission, QMS audit, Certificate
Total Timeline:
- •Optimistic: 6-9 months
- •Expected: 9-13 months
- •Pessimistic: 13-18 months
MFDS Grade 2 (Approval)
Phase 1: Preparation
- •Duration: 1-2 months
- •Deliverables: Test protocol, Documentation plan
Phase 2: Testing
- •Duration: 2-4 months
- •Deliverables: Non-clinical testing, Performance validation
Phase 3: Documentation
- •Duration: 1-2 months
- •Deliverables: Approval application package
Phase 4: MFDS Review
- •Duration: 2-4 months
- •Deliverables: Application submission, Deficiency response
Total Timeline:
- •Optimistic: 3-6 months
- •Expected: 6-10 months
- •Pessimistic: 10-14 months
Analysis Workflow
Step 1: Receive Pathway Data
Accept pathway selection results as input:
- •Selected pathways per region
- •Device class/grade per region
- •Target regions
If pathway data is not provided, return an error indicating pathway analysis is required first.
Step 2: Apply Cost Estimation Logic
For each region:
- •Identify pathway type (510(k), PMA, De Novo, CE Mark, Registration, Approval, etc.)
- •Determine device class/grade
- •Lookup cost ranges from framework above
- •Apply three-point estimate (optimistic, expected, pessimistic)
- •Break down by cost categories
Multi-region scenarios:
- •Identify shared costs (common testing, consulting overlap)
- •Calculate total cost range accounting for shared activities
- •Highlight cost-saving opportunities from parallel submissions
Step 3: Apply Timeline Estimation Logic
For each region:
- •Identify pathway milestones
- •Assign duration ranges to each phase
- •Calculate total timeline (optimistic/expected/pessimistic)
Multi-region scenarios:
- •Identify critical path (longest timeline)
- •Show parallel vs. sequential track options
- •Highlight timeline dependencies
Step 4: Assign Traffic Light
- •GREEN: Total cost < W150M, timeline < 12 months
- •YELLOW: Total cost W150-500M or timeline 12-24 months or clinical study required
Step 5: Return Structured Result
Return the estimation result containing:
- •Cost breakdown per region (optimistic/expected/pessimistic)
- •Cost category analysis
- •Timeline per region with milestones
- •Multi-region cost-saving opportunities
- •Critical path identification
- •Traffic light assessment
Traffic Light Definitions
- •GREEN: Low cost/short timeline (< W150M, < 12 months)
- •YELLOW: Moderate-high cost/long timeline (W150-500M, 12-24 months, clinical study)
- •RED: Not used (all pathways have estimates)
Escalation Scenarios
Highlight high uncertainty when:
- •Clinical trials required (cost +/-50%, timeline +/-100%)
- •Class III devices (PMA, EU MDR Class III, MFDS Grade 4)
- •Novel device categories (De Novo pathway)
- •Multi-region submissions with regulatory conflicts
Data Source Strategy
- •Built-in Knowledge (Primary): Industry average costs and timelines (2026-01)
- •Pathway Data (Input): Pathway selection results from pathway skill
- •MCP Connectors (Supplementary): Organization-specific cost data and timeline benchmarks
For MCP integration patterns (tool discovery, graceful degradation, source attribution), see CONNECTORS.md.
Note: Cost ranges are based on Korean regulatory consulting industry averages as of 2026-01. Actual costs vary by project complexity, testing requirements, and market conditions.