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An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
If some lawmakers get their way, the federal budget proposal for fiscal 2014 and 2015 now being negotiated will include a provision shielding FDA user fee revenue from any across-the-board sequestration cuts. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
Angelcare is voluntarily recalling its Movement and Sound Monitors with Sensor Pads due to the risk of a pliable cord wrapping around a baby’s neck in the crib. Read More
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last month by the Asian Harmonization Working Party. Read More
CDRH’s Office of Compliance is sharpening its focus on international inspections and audits and on labeling, adding two new divisions to meet increasing enforcement demands. Read More
The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells. Read More