Table 1.

Recommended actions to facilitate identification of clinically validated BP devices.

Action	Primary Stakeholder(s)
Mandate that all BP devices approved for sale undergo an independent clinical validation study that documents meeting the requirements of an internationally accepted validation standard (ideal state)	Governments, regulatory authorities
Stipulate clearly the changes made to a predicate (previously validated) device that should trigger re-validation versus when ‘substantial equivalence’ and a ‘letter to file’ claim can be made	Regulatory authorities
Provide an easily accessible list of marketed devices available in a country or region according to clinical validation status, with links to full-text validation study reports	Governments, regulatory authorities, manufacturers
Simplify device model nomenclature and avoid unnecessary proliferation of derivative devices or alternative naming of similar models across different regions	Manufacturers
Amalgamate validated device listings and promote their existence, importance, and use	Professional societies, device listing creators
Educate clinicians and consumers regarding the importance of clinical validation and provide simple visual tools such as universally identifiable seals or marks of approval that identify a clinically validated device at the point of sale	Governments, regulatory authorities, manufacturers, professional societies, retailers