Revised_Appendix_7_-_Glossary_of_Terms.pdf

Appendix 7

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 – Document Control Center

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)

Glossary of FDA Acronyms for Centers and Offices within FDA

Office of Operations (no acronym) Office of Information Management (OIM) Office of Management (no acronym) Office of Management/Office of Shared Services (OSS) FDA Biosciences Library (FBSL) Office of Acquisitions and Grants Services (OAGS)/Office of Field Finance and Acquisition Services (OFFAS) Office of Financial Services (OFS Office of Real Property Services (ORPS) Employee Resource and Information Center (ERIC) Office of the Chief of Staff (OCOS) Office of Public Affairs (OPA) Office of the Chief Counsel (OCC) Office of Policy, Planning, and Preparedness (OPPP) Office of International and Special Programs (no acronym) Office of Regulatory Affairs (ORA) Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) National Center for Toxicological Research (NCTR)