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Comment: Re:Woohoo! (Score 1) 130

by DeadCatX2 (#44961521) Attached to: FDA Will Regulate Some Apps As Medical Devices

That's why FDA issued this guidance. Because they were being forced to heavily regulate simple things unnecessarily. Up until now, if you wanted a doctor to use your app, you had to get it FDA approved. Now, assuming your app meets one of the exemptions, doctors can use your app more easily without potential liability (doctors tend to be paranoid about what they'll use on patients).

Comment: THIS IS RELAXING REGULATIONS (Score 1) 130

by DeadCatX2 (#44953541) Attached to: FDA Will Regulate Some Apps As Medical Devices

It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.

FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"

FDA has ALREADY been regulating medical apps. For a long time. The problem is, even if all your app does is draw pretty graphs, you still needed to go through e.g. 510K certification for your application. This guidance by FDA is aimed at reducing the barriers to entry for non-critical medical applications.

Comment: Re:Woohoo! (Score 1) 130

by DeadCatX2 (#44953479) Attached to: FDA Will Regulate Some Apps As Medical Devices

Except this is not preemptive. FDA has already been regulating medical applications on mobile platforms (quote, FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"). This guidance is saying that certain medical applications are now exempt from regulation.

Comment: LH Surge is more reliable (Score 1) 130

by DeadCatX2 (#44953389) Attached to: FDA Will Regulate Some Apps As Medical Devices

While I use My Days to track my wife's cycle, you can have improved accuracy using an LH strip. It's a "pee in a cup, stick strip into pee for three seconds, let dry for five minutes" test.

The beautiful thing is that the LH surge happens very reliably, 24-48 hours before ovulation. (see the third chart in this link and note how narrow the blue peak is compared to the other charts: http://upload.wikimedia.org/wikipedia/commons/c/c8/Hormones_estradiol%2C_progesterone%2C_LH_and_FSH_during_menstrual_cycle.svg )

I've also read (Amazon reviews, so take with appropriate amounts of salt) that if a woman has polycystic ovarian syndrome, she may not ovulate, even if she menstruates. The LH surge can tell her when she actually ovulates.

Using the LH strip in combination with My Days, you can reliably avoid or become pregnant. After a few cycles, you can tell whether My Days is correctly predicting ovulation (my wife is usually right on or a day late). Since sperm lasts up to five days, and there's some natural variations in the cycle, we generally avoid 8 days before and four days after ovulation is supposed to start. No condoms, no pill, no spermicide, and still no babies, four years running.

Comment: Stop, wait, reverse that (Score 1) 130

by DeadCatX2 (#44953279) Attached to: FDA Will Regulate Some Apps As Medical Devices

This new guidance *relaxes* the regulations, meaning that the barrier to entry for releasing a medical app has been lowered. Before Monday, if you wanted to sell a medical app on a mobile platform, you needed FDA approval. As of Monday, large swaths of medical apps are no longer required to comply with Federal Drug and Cosmetic Act.

Comment: Re:Blood glucose monitoring? (Score 1) 130

by DeadCatX2 (#44953209) Attached to: FDA Will Regulate Some Apps As Medical Devices

The headline is misleading. It implies that this is about *beginning* to regulate medical apps. In reality, medical apps have ALWAYS been regulated. The new guidelines issued by FDA *relax* the regulations, meaning that some medical apps no longer require FDA 510K approval. I have a feeling that OP's "read, parse, and analyze data" app will fit into that category, as of Monday.

This is actually a big deal to people who already have 510K. It used to be that you could say, "yeah I'm 510K" and you were one of only a few fish in a small pond. FDA just made that pond a LOT bigger, so now saying "yeah I'm 510K" isn't all that useful.

Comment: Re:If you can't control yourself ... (Score 1) 1440

by DeadCatX2 (#44941569) Attached to: Georgia Cop Issues 800 Tickets To Drivers Texting At Red Lights

That's great, if you live in an area where it's possible to pull off to the side of the road. In many places where I live, there IS no side of the road, especially when that road runs along a ravine, or the road has trees all along both sides. It's great if you want to avoid speed traps, since there's no where for a cop to park - but terrible if you need to pull over for an emergency.

Or the side of the road is a sidewalk with pedestrians. Or you're on the highway - do you really think it's a good idea to pull over on the highway?

I'm not trying to defend people who text and drive (although "sitting at a red light" != "driving", IMO) - personally I make my wife handle all phone/GPS details while I'm driving - but I think pulling over to text is more dangerous than texting at a red light. At least in my locale.

Comment: Re:If you can't control yourself ... (Score 1) 1440

by DeadCatX2 (#44941513) Attached to: Georgia Cop Issues 800 Tickets To Drivers Texting At Red Lights

The big difference between being drunk at a stoplight and texting at a stoplight is that when you put the phone down and start moving, you're no longer texting. But if you were drunk and you start moving...you're still drunk.

But for that matter, I don't know why anyone types on text messages anymore. Verbal transcription in the latest mobile OS platforms is so good that I haven't typed a message in at least a year.

Comment: Re:jerk (Score 1) 1440

by DeadCatX2 (#44940769) Attached to: Georgia Cop Issues 800 Tickets To Drivers Texting At Red Lights

I'd rather people talk on the phone while driving, than text or GPS while driving, or even talking to a passenger in the same car.

You see, when talking on the phone, your eyes are still on the road. If texting or GPS, your eyes are on the gadget. If talking to a passenger, you will inevitably look away from the road in order to observe nonverbal cues from your companion.

Uncertain fortune is thoroughly mastered by the equity of the calculation. - Blaise Pascal

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