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 Reports Declining 510(k) Times, And Other Improvements

This article was originally published in The Gray Sheet

Executive Summary

The most recent user-fee program trends report from FDA, with data current to March 31, 2014, shows improvements in 510(k) review metrics.

You may also be interested in...



FDA MDUFA III Performance, By The Numbers

Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics.

Editors' Picks: Six Themes From 2014

Industry closely scrutinized FDA's premarket review performance as the agency took steps to streamline reviews and remake the U.S. postmarket surveillance system. Meanwhile: device mega-mergers accelerated; one of the most hotly anticipated medtech innovations faltered; and national elections swept in Republican control of Congress. Here is a look back at coverage and analysis from "The Gray Sheet" on six key themes for the medical device and diagnostics industry in 2014.

Consistency Among CDRH Review Divisions Improves, But Industry Wants More

A new report from the California Healthcare Institute shows a positive convergence of performance among FDA’s device review divisions, but the biomedical industry group thinks more policy reforms that build on models from the best performing CDRH divisions and branches might be warranted.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032964

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