SOCRA 2024 Annual Conference Program Book - Flipbook - Page 79
TERMINOLOGY
PMN or 510(k) 3 Premarket Notification
QA 3 Quality Assurance
QC 3 Quality Control
QI - Qualified Investigator (Canada)
QS 3 Quality System
QSR 3 Quality System Regulation (GMP for devices)
R&D 3 Research and Development
RAPS 3 Regulatory Affairs Professionals Society
REB - Research Ethics Board
IREMS 3 Risk Evaluation and Mitigation Strategy
RIN - Regulation Identifier Number (in Unified Agenda) or Regulatory Information Number (FR Vol. 71
No. 240 75148)
SADR 3 Suspected Adverse Drug Reaction
SAE 3 Serious Adverse Event
SBR 3 Small Business Representative (ORA)
SIB 3 Special Investigations Branch (CDRH)
SMO 3 Site Management Organization
SoCRA 3 Society of Clinical Research Associates
SOP- Written Procedures, Standard Operating Procedures
SPA- Special Protocol Assessment
SR - Significant Risk (Device)
SSED 3 Summary of Safety and Effectiveness Data
The Act 3 The Federal Food, Drug, and Cosmetic Act
TPD - Therapeutic Products Directorate of Health Canada
UADE 3 Unanticipated Adverse Device Effect
UL 3 Untitled Letter
VA 3 Veterans Administration
VAI 3 Voluntary Action Indicated (FDA inspection classification)
WL 3 Warning Letter
ADDITIONAL SOURCES OF ACRONYM EXPLANATIONS
1. Acronyms Used by FDA http://www.fda.gov/ora/training/Satellite/mou/acronym.htm
2. CDER Acronym List at http://www.fda.gov/cder/handbook/acronym.htm
3. FY 2004 Annual Performance Plan; FY 2003 Revised Final Performance Plan; FY 2002
Annual Performance Report Glossary of Acronyms
http://www.fda.gov/ope/fy04plan/2004pp-mainpage.html
4. Managing Risk from Medical Product Use
http://www.fda.gov/oc/tfrm/Acronymlist.html
6. Stemming Drug Errors from Abbreviations
http://www.fda.gov/cder/drug/MedErrors/nameAbbreviations.pdf
7. FY 2004 Justification of Estimates for Appropriations Committee Glossary of Acronyms
http://www.fda.gov/oc/oms/ofm/budget/2004/Tables/glossary.htm
8. FY 2007 Budget Summary Glossary of Acronyms
http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/glossary.htm
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