USA – FDA adds transition period to electromagnetic compatibility final guidance
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic....
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
USA – AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance
The medtech lobby group AdvaMed has asked the US Food and Drug Administration (FDA) to make changes to its recent guidance on orthopedic non-spinal...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – FDA classifies slew of class II devices following de novo procedures
Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with...
USA – FDA warns that some prenatal screening tests can generate false results
Some non-invasive prenatal tests (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic...
USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The...
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...
