Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.