The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal Year 2024, as well as a list of the ...
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, ...
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year. It also named 12 ...
FORT LAUDERDALE, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies ...
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions ...
The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC), the first public-private partnership created with the sole objective of advancing medical device regulatory science, ...