(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...
The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit “cross-center” master files (MFs) that are referenced and intended to ...
HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...
TIANJIN, China, Jan. 25, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal ...
This regulatory milestone builds on AIML's prior submission of a Device Master File (MAF) to the FDA. If accepted, the MAF may support future collaborations with manufacturers interested in ...
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, ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
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