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To enable an orderly and transparent transition when the PHE ends, FDA released draft guidance documents addressing: Emergency Use Authorizations and medical devices falling under specific PHE policies. The FDA will issue final guidance documents following public comment.
To enable an orderly and transparent transition when the PHE ends, FDA released draft guidance documents addressing: Emergency Use Authorizations and medical devices falling under specific PHE policies. The FDA will issue final guidance documents following public comment.
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices...
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed...
Hiden Analytical was founded in 1981 and is presently situated in a 2,130m 2 manufacturing plant in Warrington, England with a staff of over 50.