ksb-d12-k0046

name: "KSB-D12-K0046" description: "EDSTP Engagement Framework: Understanding of FDA Emerging Digital Safety Technology Program (EDSTP) including eligibility criter..." version: "1.0.0" domain: "D12" domain_name: "Industry & Regulatory" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain edstp engagement framework" - "what is edstp engagement framework" - "apply edstp engagement framework" epa_mapping: "EPA-06, EPA-09, EPA-16" cpa_mapping: "CPA-04" regulatory_refs: ""

KSB-D12-K0046: EDSTP Engagement Framework

Overview

Domain: D12 - Industry & Regulatory Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Understanding of FDA Emerging Digital Safety Technology Program (EDSTP) including eligibility criteria, submission requirements, meeting request procedures, and program benefits for AI/ML pharmacovigilance tools. Knowledge of EDSTP interaction types (pre-submission meetings, written feedback requests, pilot participation), documentation expectations, and strategic timing for regulatory engagement. Comprehension of how EDSTP complements traditional regulatory pathways and CDRH AI/ML initiatives.

Context

• Major Section: FDA AI Regulatory Engagement
• Section: Emerging Technology Programs

EPA Mapping

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in edstp engagement framework
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Understanding of FDA Emerging Digital Safety Technology Program (EDSTP) including eligibility criteria, submission requirements, meeting request procedures, and program benefits for AI/ML pharmacovigilance tools. Knowledge of EDSTP interaction types (pre-submission meetings, written feedback requests, pilot participation), documentation expectations, and strategic timing for regulatory engagement. Comprehension of how EDSTP complements traditional regulatory pathways and CDRH AI/ML initiatives.

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D12 skills in Emerging Technology Programs
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31