Table 6.

FDA Grounds for Disapproval or Withdrawal of Approval of a Device

•The sponsor has not complied with application requirements of the IDE regulation, any other applicable regulations or statues, or any condition of approval imposed by an IRB or the FDA

•The application or report contains untrue statements or omits required material information

•The sponsor fails to respond to a request for additional information within the time prescribed by the FDA

•There is reason believe that risks to human subjects are not outweighed by anticipated benefits or the importance of knowledge to be gained

•The informed consent is inadequate

•The investigation is scientifically unsound

•There is reason to believe the device as used is ineffective

•It is unreasonable to begin or continue the investigation due to the way the device is used or inadequacy of 1) the report of prior investigations or investigational plan; 2) the methods, facilities and controls used for the manufacturing, processing, packaging, storage, and where appropriate, installation of the device; or 3) the monitoring and review of the investigation

Abbreviations as in Table 2.