510K

Application number that medical device manufacturers must file, to notify FDA of their intent to market a medical device at least 90 days in advance. Also known as Premarket Notification – PMN. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, … Read more

CBER

Center for Biologics Evaluation and Research

CDER

Center for Drug Evaluation and Research

CDRH

Center for Devices and Radiological Health

CFR

Code of Federal Regulations governs manufacturing requirements per the FDA.

CFSAN

Center for Food Safety and Applied Nutrition

CVM

Center for Veterinary Medicine

FDA

Food and Drug Administration

GxP

Good ______ Practice or Procedure – GMP, GLP, GCP, GDP

HACCP

Hazard Analysis & Critical Control Points –┬áis a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. -From FDA.gov