USA – FDA highlights updated labeling for some surgical mesh products, cautions against use...
The US Food and Drug Administration (FDA) issued a letter to healthcare providers to make sure they are aware of updated warnings and precautions...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed...
USA – FDA wants COVID test developers to shift from EUAs to traditional premarket...
The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency...
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 – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
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 final rule reduces radiological devices reporting requirements
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....
USA – FDA revises magnetic resonance guidance to reflect updated international standard
The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
