FDA

5 articles

Medical Device Security

By Jeff Fortin A recent study published by GAO caused quite a bit of uproar over medical device security. The GAO declared in its report [read more] that the FDA has not put enough oversight in the premarket approval (PMA) of certain medical devices that are susceptible to threats. In the report the GEO referred to an experiment described in…

How Are You Reducing Radiation?

By Pete MacKay A few years back the FDA launched an initiative aimed at reducing radiation exposure in patients undergoing CT scans.  Clearly there are concerns with exposing the human body to ionizing radiation, and due to the prevalence and popularity of these imaging techniques the FDA feels they are in a position to ensure proactive steps are taken to…

Medical Devices, Life Savers

By Nikhil Chauhan There's no doubt, medical devices are saving the most precious elements of nature - people's lives. The World Health Organization's video below highlights the importance of medical devices to health care.  Medical devices need to be secure and safe. My colleague Santhosh elaborated in a recent blog post on how FDA's 510(k) process is under scrutiny amidst the…

FDA’s 510(k) Process Under Scrutiny

By Santhosh Nair In September of 2009 the FDA commissioned an independent committee review of its 510(k) process, the most common method medical device manufacturers use to bring lower-risk products to market.  In their resultant report, the Institute of Medicine (IOM) recommended a complete overhaul.  Although the FDA has dismissed the recommendations, they are continuing to refine the 510(k) process.…

FDA Outlines Oversight of Mobile Medical Applications

By Peter MacKay 2011 is turning out to be an evolutionary year for the growing mobile healthcare industry.  In 2007, the iPhone, while not the first handheld applications platform, arguably revolutionized the way modern consumers use telephones.  Around this time healthcare visionaries also foresaw the integration of what I call “user space” with medical enterprises, and a general change in…