Appendix_7_-_Glossary_of_Terms.pdf
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Appendice 7
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GLOSSARY OF TERMS
GLOSSARY OF TERMS
Commonly used Acronyms
EIR- Establishment Inspection Reports
MDRL - Medical Device Registration and Listing Forms
51O(k)'s- Premarket Notifications
IDE's- Investigational Device Exemptions PMA's - Premarket Approval Applications DMF- Device Master Files
PDP's - Product Development Protocols
513(g)'s- Requests for Classifications
Pre-Sub's- Pre-submission documents
515(i)'s
HDE's- Humanitarian Device Exemption
CLIA - Clinical Laboratory Improvement Act
FDA - Food & Drug Administration
DRM - Division of Records Management
GCP- Good Clinical Practice
GLP -Good Laboratory Practice LOA - Letter of Authorization Records Quality Assurance Team
OC - Office of Compliance
ODE- Office of Device Evaluation
OIR- Office of In Vitro Diagnostics and Radiological Health
OCER- Office of Communication and Education
FOI - Freedom of Information
EDR- Electronic Document Room
DCC - Central Document Room
DR1- Main Document Room in Bldg 22, White Oak Campus HFC-130- Division of Field Investigations, Parklawn Facility
W022- White Oak Campus- Bldg. 22
W066- White Oak Campus- Bldg. 66
MPN-1 - Metro Park North- I facility
MPN-11- Metro Park North -II facility
FRC - Federal Records Center
FDAA- Food & Drug Administration Amendment Act
PA – Program Analyst
PM/CSO- Project Manager/Consumer Safety Officer (Government Employee)
CST- Consumer Safety Technician (Government Employee)
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