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

UsernamePublicRestriction

FDA Sticks With Premarket Plans In Cybersecurity Guidance

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



Device-Makers Need To Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says

A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue has evolved, as more cases of device vulnerabilities have surfaced. Among the key updates are recommendations for sponsors to submit a cybersecurity "bill of materials" in product labeling to better coordinate with end-users and to use a two-tiered risk management approach.

US FDA Pushes Further On Cybersecurity Efforts Despite Limited Resources

US FDA unveiled multiple cybersecurity-related initiatives, including two memoranda of understandings to launch information sharing organizations and playbook for health-care delivery organizations. The agency is continuing a multi-front attack in the area, despite limited resources.

Lawmakers Question FDA On Medical Device Cybersecurity Concerns

Top lawmakers on the House Energy and Commerce Committee wrote to US FDA asking what the agency is doing to ensure devices are protected against malicious hackers.

Related Content

Topics

UsernamePublicRestriction

Register

MT033368

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

Cancel