USA – New rule directs mammography facilities to tell patients about breast density
The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...
USA – Pre-submission requests for IVDs to be accepted by FDA
The FDA in January restarted accepting pre-submissions for in vitro diagnostics that would require premarket authorization or de novo clearance. Now, the agency plans...
USA – Action needed on FDA regulation of AI-based medical devices
After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety...
USA – FDA guidance explores trial design, supporting data for GVHD treatments
In preparation for a potential “paradigm shift” in the management of graft-versus-host disease (GVHD), the US Food and Drug Administration (FDA) is seeking comment...
Brazil – ANVISA announces major medical device registration updates
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
USA – FDA finalizes which clinical decision software functions it regulates
The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a...
USA – FDA eases labeling, clarifies IVD requirements in COVID transition guidances
The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to...
USA – FDA considers pilot for lower radiation levels for device sterilization
The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency...
USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos
Les procureurs ont requis 15 ans de prison contre Elizabeth Holmes, star déchue de la Silicon Valley, tandis que la défense a plaidé pour une...
