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


Companies Nervous About 'Sharing' Organizations Touted In FDA Cyber Guidance

This article was originally published in The Gray Sheet

Executive Summary

Industry groups have questions and concerns about the Information Sharing and Analysis Organizations highlighted in FDA's recent postmarket cybersecurity draft guidance. The agency's use of the term "essential clinical performance" in the document has also raised concerns, comments submitted to FDA show.


Related Content

Device-Makers Have Amped Up Defenses Against Hackers
J&J, Hacker Work Together To Fix Insulin Pump Vulnerability
St. Jude Hacking-Risk Allegations: US FDA Continues Assessment, As Firm Files Lawsuit





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