IDE Application - Notice of Disapproval or Withdrawal

An IDE application can be approved, approved with modification, or disapproved by the FDA. FDA may request additional information about an investigation.

Notice of Disapproval or Withdrawal

FDA will notify the sponsor via email, if the Agency disapproves an IDE application or suggests to withdraw approval. A disapproval order will cover a comprehensive detail of the reasons for disapproval and will advise the sponsor of the right to request a regulatory hearing under 21 CFR 16. The FDA will provide a chance for a hearing before withdrawal of approval unless the Agency determines that there is an irrational risk to the public health if testing continues.

Reasons for Disapproval or Withdrawal

FDA may disapprove or withdraw approval of an IDE application if the Agency discoveries that:

• The sponsor fails to comply with applicable IDE Regulations, or requirements of any other applicable regulations or statutes, or any condition of approval imposed by an IRB or the FDA.
• The application or a report encompasses false statements or overlooks required material information.
• The sponsor did not respond to a request for additional information within the time required by the FDA.
• There is reason to believe that the risks to the human subjects are not outweighed by the anticipated benefits to the subjects or the importance of the knowledge to be gained.
• Inadequate informed consent form.
• The investigation, as proposed, is scientifically unsound.
• There is reason to believe that the device as used is ineffective.
• It is unreasonable to begin or to continue the investigation due to the way in which the device is used or the inadequacy of:
• the report of prior investigations or the investigational plan
• the methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device
• the monitoring and review of the investigation.

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