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

FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)

You may also be interested in...



Live Case Demos: FDA Says More Data Is Needed On Impact On Patient Care

FDA and medical professional societies are considering how best to study the risks of live case demonstrations at physician meetings

Live Case Demos: FDA Says More Data Is Needed On Impact On Patient Care

FDA and medical professional societies are considering how best to study the risks of live case demonstrations at physician meetings

Guidelines Proposed For Live-Case Demonstrations

Prominent interventional cardiologists plan to create guidelines for live case demonstrations that are broadcast at professional meetings in the face of intensifying scrutiny on the practice

Related Content

UsernamePublicRestriction

Register

MT026652

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