Medtech Insight is part 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

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Pediatric device report: FDA submits its first annual 1report to Congress on pre-market approval statistics for pediatric-use devices, posted April 28. The 2007 FDA Amendments Act requires the agency to submit the reports as part of a government effort to encourage development of devices for young patients. During fiscal 2008, FDA approved 15 PMAs and panel-track supplements and two humanitarian-use devices that treat or diagnose conditions with pediatric subpopulations, including Abbott's Freestyle Navigator continuous glucose monitor and Thoratec's Heartmate II left ventricular assist system. Two devices were specifically labeled for use in pediatric patients in FY 2008
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

MT027402

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