E01¶


Research	R0021 — Prompt engineering definitions
Run	2026-03-25
Query	Q004
Source	SRC02
Evidence	SRC02-E01
Type	Factual

FDA AI/ML SaMD Guidance — key validation requirements

URL: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device

Extract¶

GMLP 10 principles; predetermined change control plans; 97% via 510(k)

Relevance to Hypotheses¶

Hypothesis	Relationship	Strength
H1	Supports	Framework exists with specific requirements
H2	Contradicts	Active regulatory framework in place
H3	Supports	Framework acknowledges adaptation challenges

Context¶

This regulatory framework demonstrates that regulated industries take AI validation seriously but are still adapting their traditional frameworks to handle AI-specific challenges.