Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:

  • Name of the product or code number

  • Batch or lot number

  • Serial number (wherever applicable)

  • Date of manufacture

  • Use-before date

  • Storage conditions

  • Name and address of the manufacturer

  • The specific purpose for which it has been manufactured

  • “For Clinical Investigation / Evaluation Only – Not for Sale”