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 

  • 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.