Draft Guidance for Industry and Staff; Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems
This Other document was issued by the Food and Drug Administration (FDA)
For related information, Open Docket Folder
| || |
Show More Details
Date Posted: Dec 6, 2011
Time in Range: Our major concern with the guidance document relates to the exclusion of Time in Range (TIR) as an acceptable primary endpoint. Unfortunately...
Dexcom participated in teleconferences with JDRF to develop additional comments submitted by JDRF.
This document is contained in
Related RINs: None
* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.