Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
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 ...
Yahoo

FDA announces regulatory exemptions for ‘non-medical grade’ devices

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
American Enterprise Institute

Congress Must Update FDA Regulations for Medical AI

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...
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 ...
MobiHealthNews

FDA clarifies the line between wellness and regulated medical devices

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...

FDA Eases Wellness Device Regulation, But Marketing Is Still Key

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...