Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA’s Latest Post-Market Plan: Data-Mining Device Safety

This article was originally published in The Gray Sheet

Executive Summary

Data-mining software tools will be used by FDA to find troubling patterns with particular devices as part of the agency’s latest plan to beef up its post-market surveillance activities.

You may also be interested in...



CDRH Details Path Forward For National Post-Market Surveillance System

The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.

ICD Lead Recall Could Have Come Sooner With Novel Surveillance Tool – Study

A retrospective analysis shows that a software analytics tool would have enabled earlier detection of Medtronic’s Sprint Fidelis defibrillator lead fracture issues and an earlier recall of the device, which was withdrawn from the market in 2007.

Automated Device Safety Surveillance Gets Proof Of Principle

Comprehensively tracking post-market safety signals presents an almost insurmountable challenge for the limited staff in FDA's device center. But a new automated computer surveillance system should be able to provide needed assistance, scientists from CDRH, Harvard University and other institutions say.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032092

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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