Notice of Disapproval or Withdrawal

If FDA disapproves an IDE application or proposes to withdraw an approval, FDA will notify the sponsor in writing. A disapproval order will contain a complete statement 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 an opportunity for a hearing before with­drawal of approval, unless FDA determines that there is an unreasonable risk to the public health if testing continues.