| 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
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in edstp engagement framework
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- 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
