All medical devices in the marketplace are required to be sold with appropriate labeling. GEMAR can help you to devise your products labeling so it is in compliance with 21 CFR Part 801. These regulations specify the minimum requirements for all devices and include the following:
  • Name and place of business

  • Intended Use

  • Adequate Directions for Use

  • Misleading Statements

  • Prominence of Required Label Statements

GEMAR can also help you to understand when the use of electronic labeling is authorized and how this labeling should be prepared - contact us for further information.