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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

F

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any…

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N

New Drug Application (NDA)

A NDA is the final step formally taken by a drug sponsor, wherein it applies…

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