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Roche Diagnostics announced the launch of its Elecsys HCV Duo assay that simultaneously detects hepatitis C virus (HCV) antigens and antibodies from a single blood sample — the first commercially available test of its kind. Read More
In the absence of a fully functional Eudamed database, the EU’s Medical Device Coordination Group (MDCG) says diagnostics companies should continue to follow individual national regulations for regulatory filings and other actions until the portal comes fully online in two years. Read More
To meet a requirement of the 21st Century Cures Act, the FDA is seeking comments for a report on the patient safety and best practices impact of nondevice software functions. Read More
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its Roanoke, Va., facility where FDA officials observed multiple quality lapses. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More