Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Releases Draft Guidance On Closed-Loop Artificial Pancreas Devices

This article was originally published in The Gray Sheet

Executive Summary

Draft issued Dec. 1 emphasizes flexible clinical trial designs to support approval of glucose monitor/insulin pump combination devices that work together without the need for patient intervention.

Advertisement

Related Content

Artificial Pancreas Guidance Allows For More Flexibility In Trial Design
Regulatory News In Brief
One Study Down, Three To Go On Animas’ First-Gen Artificial Pancreas Project
News In Brief
Groups Dislike FDA-Recommended Trial Designs For Low-Glucose Suspend Systems
Diabetes Researchers Say FDA Is Slowing Artificial Pancreas Efforts

Topics

Advertisement
UsernamePublicRestriction

Register

MT030780

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel