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
UsernamePublicRestriction

US, Canada Setting Trend For Global Cybersecurity Guidance

Executive Summary

A draft IMDRF guidance released this month aims to set the trend for how regulators around the world oversee cybersecurity of medical devices. According to experts, the document also foreshadows what sponsors can expect from the US FDA in areas such as developing a software bill of materials, as the agency updates its own cybersecurity guidances.

You may also be interested in...



Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them

The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.

Siemens Cybersecurity Expert Says Medtech Industry Has 'Perverse Incentive' To Not Disclose Vulnerabilities – Might A New Law Be The Fix?

The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."

Related Content

Topics

UsernamePublicRestriction

Register

MT125807

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

Cancel