[SystemSafety] The FAA Software Precertification Pilot Program

[Derek M Jones]

All,

I have just been looking through
"The Software Precertification (Pre-Cert) Pilot Program:
Tailored Total Product Lifecycle Approaches and Key Findings"
https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program

which appears to be a discussion document that
is free of any "key findings", although it does
say that: "FDA identified 250 KPIs and metrics."

Is the issue my lack of knowledge of FDA-speak,
or is the intent to be wishy-washy?

This report from 2019 is more substantial
"Developing a Software Precertification Program:
A Working Model v1.0"
https://www.fda.gov/media/119722/download

-- 
Derek M. Jones           Evidence-based software engineering
blog:https://shape-of-code.com