The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems
This guidance is intended to provide recommendations to Sponsors planning to develop and submit an Investigational Device Exemption (IDE) or premarket approval (PMA) application for an Artificial Pancreas Device System (APDS) for single patient use in the home environment. For the purposes of this document, the APDS refers to low glucose suspend systems, as well as closed loop control systems. FDA recognizes the need for guidance on the least burdensome means of development for these innovative device systems. Due to the evolving nature of these device systems, it is expected that they will develop incrementally. The recommendations contained in this guidance are intended to provide adequate guidance and instruction to facilitate the development and marketing of the APDS while, at the same time, allowing sufficient flexibility to accommodate the different approaches that Sponsors may wish to take.
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.