The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
In thousands of communities across the United States, drinking water is contaminated with chemicals known as perfluoroalkyl and polyfluoroalkyl substances (PFAS). PFAS are used in a wide range of ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week ...
FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is probably the most used ...
The US Food and Drug Administration (FDA) has published a new draft guidance on ways to minimize medication errors through designing products with safety considerations in mind, part of the agency's ...
The Centers for Disease Control and Prevention announced Friday that it would wind down much of its remaining guidance specifically targeted at COVID-19, including an official end to a pandemic-era ...
About 60% of healthcare workers participating in an optional rapid antigen testing program at UCLA tested positive at day five, and about 50% were positive at day seven after initially testing ...
Wisconsin Gov. Tony Evers signed an executive order to protect vaccine access after new federal limits were issued. The new federal guidance restricts updated COVID-19 shots to individuals 65 or older ...
To manage the challenges of today’s complex electrical power systems and tightening budgets, facility managers need to understand the critical connection between electrical commissioning and ...
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