The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Minimizing Risk for Children’s Toy Laser Products. ” This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health’s (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time.
Medical device manufacturers filing Investigational Device Exemption (IDE) submissions for clinical investigation approval will soon find a more efficient and updated application process, according to the US Food and Drug Administration.
India, Mexico, China, Africa, and Mideast countries represent fastest growth markets, according to new Freedonia study.
Is marijuana bad, or could it be good for some? CNN chief medical correspondent Dr. Sanjay Gupta spent a year traveling around the world to shed light on the debate.
Researchers at Harvard University have created the first noninvasive brain-to-brain interface (BBI) between a human… and a rat. Simply by thinking the appropriate thought, the BBI allows the human to control the rat’s tail. This is one of the most important steps towards BBIs that allow for telepathic links between two or more humans — which is a good thing in the case of friends and family, but terrifying if you stop to think about the nefarious possibilities of a fascist dictatorship with mind control tech.
An ongoing collaboration between the Japanese Riken Brain Science Institute and MIT’s Picower Institute for Learning and Memory has resulted in the discovery of how to plant specific false memories into the brains of mice. The breakthrough significantly extends our understanding of memory and expands the experimental reach of the new field of optogenetics.
The FDA wants a new subcommittee of its Science Board to suggest ways to improve regulatory science at the Center for Devices & Radiological Health. The FDA’s Science Board yesterday agreed to form a new subcommittee to help the agency examine 3 specified domains of regulatory science activities related to medical devices, assess progress made since 2007, and address the challenges posed by rapidly evolving science and technology.
Medical device industry lobbying group AdvaMed urges the FDA to avoid making needless changes to the 510(k) medical device review pathway, particularly to the rules for when device modifications merit a new application.
Researchers have tested an artificial pancreas that could one day improve lives of millions of people suffering from diabetes in a home environment for the first time.