Learn More about FDA Labeling

FDA Life Sciences Labeling Regulations

• FDA labeling regulations within the medical device industry include Unique Device Identification (UDI), which requires that all medical devices distributed in the United States be labeled with a UDI, comprised of a unique numeric or alphanumeric code that is used to identify medical devices within the supply chain.
  
  
• FDA 21 CFR Part 11 applies to the research, manufacturing, and distribution of pharmaceutical and medical products, and was established to protect the public health and ensure accuracy of electronic medical records.
  
  
• Drug Supply Chain Security Act (DSCSA) aims to build electronic interoperable systems to accurately trace prescription drugs throughout the supply chain. A unique product identifier is required at the prescription drug package level to meet DSCSA requirements.