Medtech Insight is part 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


FDA Proposal For Cybersecurity Info In Pre-market Submissions Generates Debate

This article was originally published in The Gray Sheet

Executive Summary

Medical device firms and internet security groups disagree over whether an FDA guidance should recommend that companies document their cybersecurity measures in pre-market submissions.

You may also be interested in...

Responding To Cybersecurity Threats: FDA Addresses Postmarket Questions In Draft Guidance

FDA issued a draft guidance on how companies should monitor and respond to potential cybersecurity threats in the postmarket setting. Some cybersecurity problems will require a recall action, but in most cases urgent notification to FDA will not be necessary, the document suggests.

FDA Sticks With Premarket Plans In Cybersecurity Guidance

A final guidance issued by the agency on premarket submission content to support device cybersecurity is consistent with last year’s proposal. FDA was not swayed by calls to allow device firms to address cybersecurity risks and mitigation efforts within design history files rather than in premarket submissions.

Hack Attack On Hospital System Highlights Need For Device Cybersecurity

Chinese hackers recently broke into Community Health Systems’ IT system and stole patient data. Although they did not take device data in this instance, the hackers might have been after that, experts suggest, highlighting vulnerabilities for industry.

Related Content


Related Companies




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