There are thousands of mobile health apps available for download, and some will be regulated as medical devices. Final guidelines are forthcoming, but what has the FDA communicated about mHealth apps until now?
The quality, safety, and effectiveness of a device is established during the design phase. A device recall can result in higher product development costs and lost revenue for the manufacturer, which ultimately affects...
A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists...
Medical device manufacturers usually do not make the component materials that go into their devices, and yet they are responsible for demonstrating that the materials in the devices are safe. Product clinical...
This informative PDF document provides full color flow diagrams that quickly show you the process by which medical devices are approved for sale in the following countries: AUSTRALIA BRAZIL CANADA CHINA EUROPE JAPAN...