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Glossary

Device User Facility

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A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician’s office, as defined in this section. School nurse offices and employee health units are not device user facilities. 

Other glossary definitions

S

Specification

A list of tests, references to analytical procedures, and appropriate acceptance criteria  

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E

Expectedness

An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described…

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