IDE SUBMISSIONS

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

 

Clinical evaluation of devices that have not been cleared for marketing requires:

  • An investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by the FDA;

  • Informed consent from all patients;

  • Labeling stating that the device is for investigational use only;

  • Monitoring of the study 

  • Required records and reports.

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.   Please click here to contact us to learn more about the IDE process and how we can assist you. 

For more information and to learn how we can address your specific needs, please

CONTACT US

E-mail: info@AltaQ.com

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Washington, DC 20009

Telephone: 301.263.0544

Fax:            509.694.9964