North America
What is the Open FDA Initiative? In June 2014, the U.S. FDA launched the “open FDA” a technology-driven initiative to make government information easily accessible to the public. The initiative was initially an order from the White House to implement a new...
North America
The Food and Drug Administration has announced that it will be increasing the fee rates and payment procedures for medical device user fees by 4.2%. What is the Medical Device User Fee? Originally established in 2002 by the Medical Device User Fee and Modernization...
North America
The U.S. Mobile Health industry is growing at a rapid rate due to numerous technological advancements. Our chart compares the industry’s annual growth rate to that of the country’s gross domestic product (GDP) over the same 10-year period. IBISWorld notes...
North America
By Michael Rugnetta– The FDA wants to encourage the development of Health IT and Mobile Apps and has expressed a hands-off approach for low-risk forms of those technologies. Is that the right approach for the FDA to take? And how hands off exactly? What can...
North America
Recently a wide range of X-ray and computerized tomography technology were discovered to be acutely vulnerable. According to researcher Scott Erven, an unnamed organization exposed intelligence on over 68,000 systems, causing alarm. Erven noted that passwords to such...
North America
by Priya Bhutani, CEO RegDesk – Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot phase, it has the potential to standardize format for...
