Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues final guidance on IDE and PMA requirements for artificial pancreas devices. CDRH plans Office of Compliance reorganization. More regulatory news.
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Guidance On Nucleic Acid-Based IVDs Recommends Analytical, Clinical Studies
An FDA final guidance released Aug. 27 on highly multiplexed microbiological in vitro nucleic-acid based diagnostics recommends studies on both the analytical and clinical performance of the devices.
CDRH Office Of Compliance Shifts To “Function-Based Structure”
FDA’s device center Office of Compliance is reorganizing. Major goals are to organize staff around functions rather than product categories, increase attention to underserved areas and strengthen the office’s international focus.
Artificial Pancreas Guidance Allows For More Flexibility In Trial Design
FDA’s final guidance on the design and clinical study of artificial pancreas systems broadens the study endpoints permissible for the devices, which aim to “close the loop” in the treatment of type 1 diabetes.