Medtech Insight is part of the Business Intelligence Division 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

Top 15 In '15: The Most-Read "Gray Sheet" Stories Of The Year

This article was originally published in The Gray Sheet

Executive Summary

The most popular "Gray Sheet" stories in 2015 dug deep into regulatory developments and concepts, and provided guidance on how to respond. Quality control topics and analysis of FDA's premarket review processes dominates the list.

Advertisement

Related Content

FDA MDUFA III Performance, By The Numbers
FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews
FDA Shoots For New 510(k) Modification Draft Guidance In 2016
Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification
Scrutinizing Substantial Equivalence: 510(k) Predicate Standard Questioned At FDLI
Industry, FDA Coming Together On Risk Management For Marketed Devices
10 Things You Should Know About The Medical Device Single-Audit Pilot
'Acting' At CDRH: Two Top Offices Are Now Run By Interim Directors

Topics

Advertisement
UsernamePublicRestriction

Register

MT034553

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