Get our free email newsletter

FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific cybersecurity practices related to the servicing of medical devices.

The discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities,” considers cybersecurity issues that are unique to the repair or routine maintenance servicing of a finished medical device. Specific cybersecurity aspects addressed in the paper include 1) privileged access; 2) identification of cybersecurity vulnerabilities and incidents; 3) prevention and mitigation of cybersecurity vulnerabilities; and 4) product lifecycle challenges and opportunities.

The paper is part of the FDA’s “total product lifecycle (TPLC)” approach to strengthening the overall cybersecurity of medical devices.

- Partner Content -

A Dash of Maxwell’s: A Maxwell’s Equations Primer – Part One

Solving Maxwell’s Equations for real life situations, like predicting the RF emissions from a cell tower, requires more mathematical horsepower than any individual mind can muster.

Read the FDA’s discussion paper on cybersecurity practices for the servicing of medical devices. Stakeholder comments on the discussion paper can be made until September 22 through the Regulations.gov website (reference Docket ID FDA-2021-N-0561).

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.