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 April

This article was originally published in The Gray Sheet

Executive Summary

A podcast interview and a feature story delving into the recent international ISO 13485 quality systems standard revision were the most popular items at last month. Our continuing coverage of off-label communication questions in the courts and the laboratory-developed test debate attracted attention, along with a piece on biocompatibility testing tips from FDA officials. Also: popular Gray Sheet podcasts from April.


Related Content

FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing Methods To Choose From
Don't Finalize LDT Guidance, House Appropriators Tell FDA
Lab Group Urges FDA To Wait For Congress On LDT Issue
Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing


Related Companies




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