Medical devices face potentially greater cyberthreats as the devices become more complex, Jessica Wilkerson, senior cyber policy adviser and medical device cybersecurity team lead in the FDA’s ...

As devices come onto the market that have to follow the new FDA guidance of SBOMs and patching, backdoors may become easier ...

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

The FDA seeks the advice of healthcare professionals on medical device labeling and has opened a 60-day comment period, according to a Mass Device report. The survey aims to find out healthcare ...

Please use one of the following formats to cite this article in your essay, paper or report: APA. Moore, Sarah. (2023, June 16). Beyond the Surface: the Hidden Power of Medical Device Labeling.

Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United ...

An overview of the legal framework and policies for marketing and advertising drugs and medical devices (medical products) regulated by the US Food and Drug Administration (FDA).

Manufacturers of medical devices must now show regulators when they apply to the FDA for authorization that they can monitor and address cybersecurity threats once products are on the market.

On February 2, 2024, the FDA issued the first of these policies: a final rule amending the medical device Current Good Manufacturing Practice requirements of the Quality System Regulation (QSR) to ...