510(k) — Pre-market notification for medical devices substantially equivalent to products already on the market

 

AADA — Abbreviated Antibiotic Drug Application

 

ADE — Adverse Drug Event

 

ADAA — Animal Drug Availability Act (of 1996)

 

ADR — Adverse Drug Report

 

AERS — Adverse Events Reporting System

 

AHI — Animal Health Institute

 

AIDS — Acquired Immune Deficiency Syndrome

 

ANDA — Abbreviated New Drug Application

 

ANSI — American National Standards Institute

 

BLA — Biologic License Application

 

BIMO — BIo-research MOnitoring (system);

see also Bioresearch Monitoring Information File at:  http://www.fda.gov/cder/foi/special/bmis/

 

BRMS — Biologics Regulatory Management System

 

BSE — Bovine Spongiform Encephalopathy (Mad Cow Disease)

 

CABS — Conformity Assessment Bodies

 

CARS — Compliance Achievement Reporting System

 

CBER — FDA Center for Biologics Evaluation and Research

 

CDC — Centers for Disease Control and Prevention

 

CDER — FDA Center for Drug Evaluation and Research

 

CDRH — FDA Center for Devices and Radiological Health

 

CFSAN — FDA Center for Food Safety and Applied Nutrition

 

CGMPs — Current Good Manufacturing Practices

 

CJD — Creutzfeldt-Jakob disease

 

CMC — Chemistry, Manufacturing, and Controls

 

COMSTAT — Compliance Status Information System

 

CRADA — Cooperative Research and Development Agreement

 

CRS — Contamination Response System

 

CTS — Correspondence Tracking System

 

CVM — FDA Center for Veterinary Medicine

 

DHHS — Department of Health and Human Services

 

DNA — Deoxyribonucleic acid

 

DOD — Department of Defense

 

DoL — Department of Labor

 

DQRS — Drug Quality Reporting System

 

DRLS — Drug Registration and Listing System

 

DSHEA — Dietary Supplement Health and Education Act

 

EDR — Electronic Document Room

 

EDMS — Electronic Data Management System

 

EIP — Emerging Infection Program

 

EIR — Establishment Inspection Report

 

ELA — Establishment License Application

 

EPA — Environmental Protection Agency

 

ERS — Economic Research Service

 

ETS — Environmental Tobacco Smoke

 

EU — European Union

 

FACTS — Field Accomplishment and Compliance Tracking System

 

FAO — United Nations Food and Agricultural Organization

 

FAS — USDA Foreign Agriculture Service

 

FDAMA — Food and Drug Administration Modernization Act of 1997

 

FD&C Act — Federal Food, Drug and Cosmetic Act

 

FIS — Field Information System

 

FLQ — Fluoroquinolone

 

FORCG — Food Outbreak Coordination Response Group

 

FPL — Final Printed Label

 

FPLA — Fair Packaging and Labeling Act

 

FSI — National Food Safety Initiative

 

FSIS — Food Safety Inspection Service (USDA)

 

FTC — Federal Trade Commission

 

FTE — Full-time equivalents

 

FY — Fiscal Year (October – September)

 

GAO — Government Accounting Office

 

GAPs — Good Agricultural Practices

 

GATT — General Agreement on Tariffs and Trade

 

GPRA — Government Performance and Results Act of 1993

 

GMPs — Good Manufacturing Practices

 

GRAS — Generally Recognized as Safe food ingredients

 

GSFA — General Standards for Food Additives

 

HACCP — Hazard Analysis Critical Control Points (a quality assurance and inspection technique)

 

HDE — Humanitarian Device Exemption

 

HIV — Human Immunodeficiency Virus

 

HUD — Humanitarian Use Device

 

ICH — International Conference on Harmonization

 

IDE — Investigational Device Exemption

 

INAD — Investigational New Animal Drug

 

INADA — Investigational New Animal Drug Application

 

IND — Investigational New Drug

 

IOM — Institute of Medicine

 

ISO — International Standards Organization

 

ISRS — Individual Safety Reports

 

IT — Information technology

 

JIFSAN — Joint Institute for Food Safety and Applied Nutrition

 

LACF — Low Acid Canned Foods

 

LAN — Local Area Network

 

MATS — Management Assignment Tracking System

 

MDR — Medical Device Reporting system

 

MOU — Memorandum of Understanding

 

MPRIS — Mammography Program Reporting and Information Systems

 

MQSA — Mammography Quality Standards Act

 

MRA — Mutual Recognition Agreement

 

NADA — New Animal Drug Application

 

NAFTA — North Atlantic Free Trade Agreement

 

NAFTA TWG — North American Free Trade Agreement Technical Working Group

 

NARMS —  National Antimicrobial Resistance Monitoring System

 

NASS — National Agricultural Statistics Survey

 

NCI — National Cancer Institute

 

NCIE — Notice of Claimed Investigational Exemptions

 

NCTR — FDA National Center for Toxicological Research

 

NDA — New Drug Application

 

NDE/MIS — New Drug Evaluation Management Information System

 

NIAID — National Institute of Allergy and Infectious Diseases

 

NIDA — National Institute on Drug Abuse

 

NIEHS — National Institute for Environmental Health Sciences

 

NIH — National Institute of Health

 

NLEA — Nutrition Labeling and Education Act

 

NME — New Molecular Entity

 

NPR — National Partnership for Reinventing Government

 

NRC — National Research Council

 

NTP — National Toxicology Program

 

NVPO — National Vaccine Program Office

 

OASIS — Operational and Administrative System for Import Support

 

OBRR — Office of Blood Research and Review

 

OPA — CFSAN, Office of Premarket Approvals

 

ORA — FDA Office of Regulatory Affairs

 

ORISE — Oak Ridge Institute for Science and Education

 

OSHA — Occupational Safety and Health Administration

 

OTC — Over-the-counter

 

OTR — Office of Testing and Research (CDER)

 

PAS — FDA Public Affairs Specialist

 

PDPs — Product Development Protocols

 

PDUFA — Prescription Drug User Fee Act of 1992

 

PIFSI — Produce and Food Safety Initiative

 

PLA — Product License Application

 

PMA — Premarket Approval (Application to market medical device that requires premarket approval)

 

PODS — Project-Oriented Data System

 

PQRI — Product Quality Research Initiative

 

QSIT — Quality System Inspection Technique

 

RA — Rheumatoid Arthritis

 

RCHSA — Radiation Control for Health and Safety Act

 

REGO — Reinventing government initiative

 

RIMS — Regulatory Information Management Staff

 

RVIS — Residue Violation Information System

 

SAB — Science Advisory Board

 

SAMHSA — Substance Abuse and Mental Health Services Administration

 

SE — Salmonella Enteriditis

 

SN/AEMS — Special Nutritional Adverse Events Monitoring System

 

STARS — Submission Tracking and Review System

 

StmDT104 —  Salmonella typhimurium DT 104

 

TB — Tuberculosis

 

TRIMS — Tissue Residue Information System

 

UK — United Kingdom

 

UMCP — University of Maryland-College Park

 

USDA — Unites States Department of Agriculture

 

VAERS — Vaccine Adverse Event Reporting System

 

VFD — Veterinary Feed Directive

 

VICH — Veterinary International Conference on Harmonization

 

WHO — United Nations World Health Organization

 

WTO — World Trade Organization