When a company learns that it has a device that violates FDA law, it is required to recall the device and then notify the FDA. GEMAR can help you to understand what is required by 21 CFR 7 and assist you in the steps necessary to meet these requirements:
  • To help with a plan to contact the customers who received the device directly from the company and to notify others through press releases

  • To supply information to help users identify the device and take steps to minimize any health consequences

  • To work with the FDA and you to obtain information about the product, the problem, the recall strategy, and the steps that need to be taken to prevent the problem from happening again

  • To conduct a pre-audit to make sure that the recall efforts are appropriate and effective prior to the FDA inspection

  • To prepare periodic recall status reports for filing with the appropriate FDA field office. 

GEMAR is experienced and can help you to meet the requirements for recalling your device - contact us for further information.