The US Food and Drug Administration (FDA) has recommended guidelines on the postmarket management of medical devices in a bid to secure the equipment from cyberattacks.

The newly released guidance follows an earlier final guidance on medical device premarket cybersecurity which was issued in 2014.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

A significant progress in the technological field of medical device technology makes the devices vulnerable to increased risk of cybersecurity breaches which can hamper the device’s performance and functionality, FDA stated in its blog.

"The recently released guidance by FDA stresses on creating a structured and comprehensive programme by the manufacturers to address cybersecurity threats."

In order to contain the threats, manufacturers are required to include cybersecurity controls in the design of the device to ensure seamless product performance and should also continuously monitor and combat cybersecurity concerns after the product is launched and used by patients.

The recently released guidance by FDA stresses on creating a structured and comprehensive programme by the manufacturers to address cybersecurity threats.

See Also:

The programme should explore ways to continuously identify and monitor cybersecurity threats, understand the gravity of the threats and its effect on patient’s safety.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

FDA stresses on cooperation with cybersecurity researchers and other stakeholders to be informed on potential vulnerabilities as well as implement mitigations such as software patches for an early addressing of cybersecurity issues.

Execution of the guiding principles along with the National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity is safeguard medical equipment from cyber threats.

FDA intends to cooperate with medical device cybersecurity stakeholders in order to address potential cyber threats and subsequently make adjustments in its guidelines.