Status
State the pathway and authorised wording accurately.
Scope boundary · 18
Authorisation is not superiority
Keep legal market status separate from comparative claims about safety, outcomes, efficiency or value.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
18
FUURAA thesis
Authorisation answers whether defined evidence supports defined use—not whether one pathway is best for every patient or institution.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Comparison
Require direct or defensible comparative evidence for superiority.
Context
Account for patient mix, expertise, alternatives and implementation.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
What did the regulator actually decide?
- 02
Is superiority in the label?
- 03
Was comparison prespecified?
- 04
Who may not benefit?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Authorisation-language extract
- 02
Evidence package 2
Comparative evidence appraisal
- 03
Evidence package 3
Population and implementation limits
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Regulatory logos, database inclusion or an innovation pathway must not be presented as endorsement.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗02Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
European Commission MDCG · MDCG 2020-1 · March 2020
↗03Clinical evaluation and performance evaluation of medical device software
Connects valid clinical association, technical performance and clinical performance to a documented evaluation under the applicable regulation.
China NMPA · Published 2025-07-03
↗Lifecycle regulation measures supporting high-end medical devices
Calls for classification guidance for surgical and rehabilitation robots, naming consensus, standards work and lifecycle regulatory support.