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The FDA's Center for Biologics Evaluation and Research (CBER) recently posted a recall notice for two lots of Ortho-Clinical Diagnostics' Fetalscreen test.
A recent trend among some European Union (EU) members to apply clinical trial regulations for medicines to medical devices is ill conceived and not in the interest of device manufacturers, according to a position paper released by Eucomed, the European medical technology industry association.
Reps. Louise Slaughter (D-N.Y.) and Judy Biggert (R-Ill.) announced the mark up of the Genetic Information Non-Discrimination Act (GINA), H.R.493, in the House Committee on Education and Labor.
Splintek, a division of Power Products, must stop marketing its Sleep Right adjustable night guard for OTC purchase because the company did not gain premarket approval to sell the device without a prescription, an FDA warning letter said.
Australia's High Court granted special leave for the Australian Competition and Consumer Commission (ACCC) to appeal findings by the country's Full Federal Court that Baxter Healthcare was protected from the application of the 1974 Trade Practices Act by crown (or sovereign) immunity, the ACCC said in a recent statement.
The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
Siemens Medical Solutions has reportedly reached an agreement with the U.S. Attorney's Office for the Northern District of Illinois to settle allegations made in an indictment filed in January 2006.