Consultants specialising in regulatory affairs




IDE: Investigational Device Exemption


An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification (510K). Involved in this process is an approved clinical protocol, administrative monitoring plan, IRB approval, patient informed consent form, etc. in order for the manufacturer to gather the clinical information on humans to establish the safety and effectiveness data.

Whatever the route required for your company's medical product, we are experienced in every aspect of the process and will assist you in addressing the following mandatory IDE requirements:

  • Required administrative IDE elements, such as;

    • Report of prior investigations
    • Bibliography
    • Published and unpublished adverse information
    • Copies of other significant publications requested by FDA
    • Summary of unpublished information (supportive or adverse) that is relevant to the safety and effectiveness of your medical device
    • Nonclinical laboratory conducted in compliance with Good Laboratory Practices (GLP) regulation 21 CFR Part 58.
    • Investigational Plan (21 CFR 812.25)
  • Ensuring your company has met all of the suggested content of the original IDE Application Cover Letter
  • Ensuring your company has met the suggested format for the IDE Submission

    • Indications for Use
    • Description of the medical device

      • Safety testing (if applicable)
    • Sample size consideration
    • Investigational Plan
    • Product labels
    • Administrative Plan with Data Collection Forms
    • Patient Informed Consent Form
    • IRB Approval
    • Sales history outside United States
  • Ensuring your company is not filing their IDE if the following areas are deficient:

    • Inadequate report of prior investigations
    • Inadequate investigational plan
    • Inadequate/Incomplete design and manufacture information
    • Inadequate laboratory studies
  • IDE Reports

    • Unanticipated Adverse Device Effects
    • Withdrawal of IRB Approval
    • Withdrawal of FDA Approval
    • Progress Reports
    • Deviations from the Investigational Plan
    • Recalls and Device Disposition
    • Final Report