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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
Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency, saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More
The U.S. Food and Drug Administration has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More