If my mind is half-way functional today, it was recently ruled that the Food and Drug Administration (FDA) had not the jurisdiction to regulate e-cigarettes. Anyone want to bet on what happens concerning FDA attempts to regulate electronic applications? The question is brought to mind by another Slashdot.org posting (below). BTW: they ban candy cigarette sales to minors, but a 12-year-old can buy an e-cig??? An e-cig is considered, by some, to be a gateway drug.
FDA Will Regulate Some Apps As Medical Devices12
Posted by
Soulskillon Tuesday September 24, 2013 @04:03PM
from the software-is-hardware dept.
chicksdaddy writes
"In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, 'when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"
I throw in a non-sequitur, just for fun*, also from Slashdot.org:
Romanian Science Journal Punked By Serbian Academics88
Posted by
Unknown Lameron Tuesday September 24, 2013 @05:01AM
from the groundbreaking-research dept.
schwit1 writes
"A group of Serbian academics, disgusted with the poor state of their country's research output, have scammed a Romanian science journal by getting it to accept their completely fabricated hoax article. From the article: 'The paper is replete with transparent gimmicks — obvious, that is, had anyone at the publication been paying attention — including a reference to the scholarship of [singer Michael] Jackson, Weber, [porn star Ron] Jeremy and citations to new studies by Bernoulli and Laplace, both dead more than 180 years (Weber died in 1920). They also throw in references to the "Journal of Modern Illogical Studies," which to the best of our knowledge does not and never has existed (although perhaps it should), and to a researcher named, dubiously, "A.S. Hole." And, we hasten to add, the noted Kazakh polymath B. Sagdiyev, otherwise known as Borat.' Their paper is hilarious and completely ridiculous, and yet it was published in a so-called serious journal without question. The best part is that they list Alan Sokal's hoax paper from 1996 as one of their sources."
_____________
* I point out, as part of the "fun", that my Hunky Husband is 50% Serbian.
The Serbian paper is hilarious! Obviously the editor of the journal never read it or he/she would have realised they were getting their leg pulled. That said, some friends back in the 1980s once egged one another on for a bet to see who could get the most "simple-minded" paper published. I got one in "Angewandte Informatik", which, luckily, Google Scholar does not list :-) And I didn't even need to descend into the humanities ;-)
Posted by: Ole Phat Stu | September 25, 2013 at 05:57 AM
Stu--Although I was able to find a listing of eight papers of yours that were published in Angewandte Informatik during the 1980s, I could not download the papers in order to isolate the funny one. Sorry to have missed out on the fun.
Some of the funniest "papers" that I've read were in the 1950s, in the April issue of QST* or 73* (I don't recall which - perhaps it was both) who made it a habit of including one "April fool's" article each April.
________
* For those unfamiliar with QST and 73, I'll explain that they are magazines published for consumption by amateur radio operators.
Posted by: Cop Car | September 25, 2013 at 07:56 AM
P.S. At least one of the April fool's articles turned out to be prescient - portending black holes. The subject of the paper was a lightbulb that gathered in light. Yes, I know that the forerunner of black hole theory was postulated in the 18th century; but, I was pretty sure the guy was just twitting us (as opposed to "tweeting") as the theory of black holes was not widely publicized and the writers in the ham magazines were not, in general, that knowledgeable. Perhaps I short-changed that author?
Posted by: Cop Car | September 25, 2013 at 08:05 AM
When I was interviewing last year, one of the top 3 companies that I wanted to work for (and who interviewed me 3 times) does something very similar to the phone apps described.
Posted by: bogie | September 28, 2013 at 05:52 AM
Bogie--Interesting. I recall that you were enthusiastic about the prospects, had you hired on there. You could have given us the inside scoop!
Posted by: Cop Car | September 28, 2013 at 02:22 PM