Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

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Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
MD&M East

Navigating FDA's Evolving Cybersecurity Requirements for Medical Device Manufacturers

As cybersecurity threats have become more and more pressing in the healthcare industry in the last several years, FDA has taken several steps to strengthen the security of medical devices seeking ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...
Yahoo

Chatbots Are Not Medical Devices

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...