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

In Case You Missed It: Top 10 "Gray Sheet" Stories In October

This article was originally published in The Gray Sheet

Executive Summary

Our most popular stories last month focused on how device firms respond to FDA inspection reports; guidelines from the agency on how to handle manufacturing site changes; product labeling matters; and off-label marketing rules, among other topics.


Related Content

FDA Shoots For New 510(k) Modification Draft Guidance In 2016
Absorbing Debate: Boston Sci, Abbott Differ On Whether The Future Of Stents Is To Disappear
Breakthrough Reimbursement Proposals Percolate From FDA, Industry
Proposed Intended-Use Amendments Invite Questions About FDA's Off-Label Intentions
Vascular Solutions Alleges Misconduct In Off-Label Case