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

New Survey Aims To Convey 510(k) Concerns To Policymakers

This article was originally published in The Gray Sheet

Executive Summary

Researchers from Northwestern and Stanford universities are planning to survey thousands of device industry reps in hopes of giving the Institute of Medicine a clearer picture of challenges faced within the 510(k) clearance process.

You may also be interested in...



To Speed Guidance Development, CDRH Will Need More Resources – Shuren

FDA's device center wants to improve the predictability of its product review process with more guidance documents, but lacks the personnel and resources to fully deliver, according to center director Jeffrey Shuren.

To Speed Guidance Development, CDRH Will Need More Resources – Shuren

FDA's device center wants to improve the predictability of its product review process with more guidance documents, but lacks the personnel and resources to fully deliver, according to center director Jeffrey Shuren.

Firms Find FDA Less Efficient, Less Competent Than European Counterparts

Inefficiencies in the FDA review process, such as high rates of staff turnover, are substantially increasing costs and time to market compared to Europe, according to a survey of small to mid-sized device manufacturers.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT029747

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