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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

U

Use error

An act or omission of an act that results in a different medical device response…

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P

Patient Information Leaflet (PIL)

Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally…

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