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Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclusion of their devices in the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration says. Read More
Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More
India’s Ministry of Health and Family Welfare said it will create a Medical Technology Assessment Board to evaluate existing and new technologies and accelerate production by local devicemakers. Read More
Sponsors of clinical trials in India must inform enrollees during videotaped informed consent sessions about potential payments resulting from adverse events, a draft guideline says. Read More
The FDA and American Glaucoma Society will hold a workshop to discuss clinical trial design and safety parameters for minimally invasive glaucoma surgery. Read More
An institutional review board at one of Chicago’s major hospitals was handed an FDA warning letter for a slew of violations — many cited previously — in a medical device clinical trial. Read More
A Kentucky hospital has agreed to pay $16.5 million in restitution to resolve allegations it billed Medicare and Medicaid for cardiac implants that were not medically necessary, in violation of the False Claims Act. Read More
Postmarket studies for devices known to affect men and women differently should be engineered to enroll more female patients, the FDA says following publication of a review of postmarket studies by CDRH scientists. Read More
The Court of Appeals for the Federal Circuit should dismiss an appeal from Consumer Watchdog because the group lacks standing to challenge a stem cell patent held by Wisconsin Alumni Research Foundation, according to an amicus brief filed by the U.S. Department of Justice. Read More
Legislation establishing a device regulatory framework in Malaysia took effect just six months ago, and the Medical Device Authority wants to hear from stakeholders on how implementation and the transition to establishment licensing and device registration is going. Read More