Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

Issue Date: April 15, 2008
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Investigational Device Exemption (IDE)
Status: Final

Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

FDA has developed this guidance document to assist industry in preparing Investigational Device Exemption (IDE) applications for nocturnal home hemodialysis (NHHD) systems. These dialysis devices are intended to administer dialysis therapy in the home setting, while the patient is expected to be asleep. FDA’s guidance documents, including this guidance , do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Download the Guidance Document