AgentSkillsCN

aria-pathway

针对FDA、欧盟MDR以及MFDS的监管提交路径分析与建议。依据设备分类评估提交途径，并结合时间线，提供具有战略意义的路径建议。

SKILL.md
--- frontmatter
name: aria-pathway
description: >
  Regulatory submission pathway analysis and recommendation for FDA, EU MDR, and MFDS.
  Evaluates submission routes based on device classification and provides strategic pathway recommendations with timelines.
allowed-tools: Read Grep Glob
user-invocable: false
metadata:
  version: "0.1.0"
  category: "domain"
  status: "active"
  updated: "2026-02-12"
  modularized: "false"
  tags: "pathway, regulatory, FDA, EU-MDR, MFDS, submission, 510(k), PMA, CE-mark"
  knowledge-base-date: "2026-01"

# MoAI Extension: Progressive Disclosure
progressive_disclosure:
  enabled: true
  level1_tokens: 100
  level2_tokens: 2500

# MoAI Extension: Triggers
triggers:
  keywords: ["pathway", "submission route", "regulatory pathway", "510(k)", "PMA", "CE mark"]
  phases: ["run"]

Regulatory Pathway Analysis Skill

Purpose

Identify regulatory submission pathways for FDA, EU MDR, and MFDS based on device classification. This is a pure analysis unit that receives classification results and returns pathway recommendations.

Input: Device classification results (FDA Class I/II/III, EU Class I/IIa/IIb/III, MFDS Grade 1-4) Output: Pathway recommendations, timeline ranges, key requirements, traffic light indicator Knowledge Base Date: 2026-01

Decision Framework

FDA Pathways

Class I Devices

  • •

    510(k) Exempt: Devices listed in exempt categories (21 CFR 862-892)

    • •Pathway: Registration only
    • •Timeline: 1-2 months
    • •Requirements: Establishment registration, Device listing
    • •Traffic Light: GREEN
  • •

    510(k) Required: Class I devices not in exempt categories

    • •Pathway: 510(k) Premarket Notification
    • •Timeline: 3-6 months (standard) or 1-3 months (expedited)
    • •Requirements: Substantial equivalence to predicate device
    • •Traffic Light: GREEN

Class II Devices

  • •

    510(k) Premarket Notification (most common)

    • •Pathway: 510(k) submission with predicate device
    • •Timeline: 3-6 months (standard) or 1-3 months (expedited)
    • •Requirements: Predicate search, substantial equivalence demonstration, performance testing
    • •Traffic Light: GREEN
  • •

    De Novo Classification Request

    • •When: No valid predicate exists, low-moderate risk device
    • •Timeline: 6-12 months
    • •Requirements: Special controls, risk mitigation documentation
    • •Traffic Light: YELLOW (escalate to expert)

Class III Devices

  • •

    PMA (Premarket Approval)

    • •Pathway: Full clinical study and PMA submission
    • •Timeline: 12-18+ months
    • •Requirements: Clinical data, manufacturing quality system, risk analysis
    • •Traffic Light: YELLOW (escalate to expert)
  • •

    HDE (Humanitarian Device Exemption)

    • •When: Rare disease (<8,000 patients/year in US)
    • •Timeline: 9-15 months
    • •Requirements: IRB approval, probable benefit demonstration
    • •Traffic Light: YELLOW (escalate to expert)

EU MDR Pathways

Class I Devices

  • •

    Self-Declaration (Annex IV)

    • •When: Non-sterile, non-measuring function
    • •Pathway: Technical documentation + DoC
    • •Timeline: 2-4 months
    • •Requirements: Technical file, risk management, clinical evaluation
    • •Notified Body: Not required
    • •Traffic Light: GREEN
  • •

    Notified Body Certification (Annex IV for sterile/measuring)

    • •When: Sterile or with measuring function
    • •Pathway: Technical documentation + Notified Body review
    • •Timeline: 4-6 months
    • •Requirements: Technical file, sterility validation (if sterile)
    • •Traffic Light: GREEN

Class IIa Devices

  • •Notified Body Certification (Annex IX or X)
    • •Pathway: QMS certification (Annex IX) or Type Examination (Annex X)
    • •Timeline: 6-12 months
    • •Requirements: Technical documentation, Clinical Evaluation Report, Post-Market Surveillance Plan
    • •Traffic Light: YELLOW (moderate complexity)

Class IIb Devices

  • •Notified Body Certification (Annex IX or X)
    • •Pathway: Full QMS certification (Annex IX) or Type Examination + Product QMS (Annex X)
    • •Timeline: 8-14 months
    • •Requirements: Technical documentation, Clinical Evaluation Report, PMCF plan
    • •Traffic Light: YELLOW (moderate-high complexity)

Class III Devices

  • •Notified Body Full QMS Certification (Annex IX)
    • •Pathway: Full QMS review + clinical investigation
    • •Timeline: 12-18+ months
    • •Requirements: Clinical investigation data, comprehensive technical documentation
    • •Traffic Light: YELLOW (escalate to expert)

MFDS Pathways

Grade 1

  • •Product Registration (제품 신고)
    • •Pathway: Registration with MFDS
    • •Timeline: 1-3 months
    • •Requirements: Product specifications, labeling, manufacturing documentation
    • •Clinical Data: Not required
    • •Traffic Light: GREEN

Grade 2

  • •Product Approval (제품 허가)
    • •Pathway: Pre-market approval submission
    • •Timeline: 3-9 months
    • •Requirements: Non-clinical test data, risk analysis, labeling
    • •Clinical Data: Non-clinical testing sufficient for most devices
    • •Traffic Light: GREEN to YELLOW (depending on complexity)

Grade 3

  • •Product Approval with Clinical Data (제품 허가)
    • •Pathway: Pre-market approval with clinical/non-clinical data
    • •Timeline: 9-15 months
    • •Requirements: Clinical or comprehensive non-clinical data, risk management
    • •Traffic Light: YELLOW (escalate to expert)

Grade 4

  • •Product Approval with Clinical Trial (제품 허가 with 임상시험)
    • •Pathway: Clinical trial + pre-market approval
    • •Timeline: 12-18+ months
    • •Requirements: IRB-approved clinical trial, comprehensive clinical data
    • •Traffic Light: YELLOW (escalate to expert)

Analysis Workflow

Step 1: Receive Classification Data

Accept classification results as input:

  • •FDA Class (I/II/III)
  • •EU MDR Class (I/IIa/IIb/III)
  • •MFDS Grade (1/2/3/4)
  • •Target regions

If classification data is not provided, return an error indicating classification is required first.

Step 2: Select Pathways per Region

FDA Pathway Selection Logic:

  • •Class I + Exempt -> Registration only (GREEN, 1-2 months)
  • •Class I + Non-exempt -> 510(k) (GREEN, 3-6 months)
  • •Class II + Valid predicate -> 510(k) (GREEN, 3-6 months)
  • •Class II + No predicate -> De Novo (YELLOW, 6-12 months)
  • •Class III -> PMA (YELLOW, 12-18+ months)

EU MDR Pathway Selection Logic:

  • •Class I (non-sterile, non-measuring) -> Self-declaration (GREEN, 2-4 months)
  • •Class I (sterile or measuring) -> Notified Body Annex IV (GREEN, 4-6 months)
  • •Class IIa -> Notified Body Annex IX/X (YELLOW, 6-12 months)
  • •Class IIb -> Notified Body Annex IX/X (YELLOW, 8-14 months)
  • •Class III -> Notified Body Annex IX + Clinical Investigation (YELLOW, 12-18+ months)

MFDS Pathway Selection Logic:

  • •Grade 1 -> Registration (GREEN, 1-3 months)
  • •Grade 2 -> Approval (GREEN-YELLOW, 3-9 months)
  • •Grade 3 -> Approval with clinical data (YELLOW, 9-15 months)
  • •Grade 4 -> Approval with clinical trial (YELLOW, 12-18+ months)

Step 3: Multi-Region Comparison

When multiple target regions selected:

  • •Generate comparison table: Region | Pathway | Timeline | Key Requirements
  • •Identify critical path (longest timeline)
  • •Highlight common dependencies (e.g., shared testing data)
  • •Recommend parallel vs. sequential submission strategy

Step 4: Assign Overall Traffic Light

  • •GREEN: All pathways are low-risk (Class I/IIa, Grade 1-2, no clinical trials)
  • •YELLOW: Any pathway requires Notified Body, clinical data, or De Novo/PMA

Step 5: Return Structured Result

Return the pathway analysis containing:

  • •Selected pathway per region with rationale
  • •Timeline ranges (optimistic/expected/pessimistic)
  • •Key requirements per pathway
  • •Multi-region comparison (if applicable)
  • •Critical path identification
  • •Traffic light assessment

Traffic Light Definitions

  • •GREEN: Low-risk pathways (Class I/IIa, Grade 1-2, no clinical trials, no Notified Body for complex reviews)
  • •YELLOW: Moderate-high risk (Class IIb/III, Grade 3-4, De Novo, PMA, clinical trials required, Notified Body for Class IIb/III)
  • •RED: Not used in pathway skill (all valid classifications have a pathway)

Escalation Scenarios

Escalate to regulatory expert when:

  • •FDA Class III device (PMA pathway)
  • •EU MDR Class III device (clinical investigation required)
  • •MFDS Grade 4 device (clinical trial required)
  • •De Novo pathway (no predicate device)
  • •Multi-region submission with conflicting timelines

Data Source Strategy

  1. •Built-in Knowledge (Primary): Embedded pathway frameworks from FDA, EU MDR, MFDS regulations
  2. •Classification Data (Input): Classification results from determination/classification skills
  3. •MCP Connectors (Supplementary): Organization-specific pathway precedents and timeline data

For MCP integration patterns (tool discovery, graceful degradation, source attribution), see CONNECTORS.md.