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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

D

Development safety update report (DSUR)

Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…

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C

Critical Process Parameter (CPP)

A process parameter whose variability has an impact on a critical quality attribute and therefore…

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