FDA: We Can't Scale To Regulate Mobile Health Apps

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.

Comments

Charge what it costs to certify

[Anonymous Coward]

Just charge what it costs to certify that an application/ device does what it claims to do. I know it is a novel concept of fee for service, but things are far more transparent that way. If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Re:Charge what it costs to certify

[Rockoon]

Everything you said is unimportant because the FDA's purpose isnt supposed to be enforcing efficacy, only safety.

Somewhere along the way, however, some blind fool tools such as yourself got the FDA into the safety efficacy racket, and the thing that took a back seat because of it was in fact safety.


Let me quote you: "if it can't be overseen by the government it need to either be banned." Not only is this a grammatic fail, even if it was grammatically correct it would still just be a full blown blind call for complete Statism.

Re:Charge what it costs to certify

[Bing Tsher E]

That is completely garbage. The Underwriter's Laboratory is a private for-profit organization and does a very good job of assuring fire and electrical safety for a huge sector of industry. When something is UL listed you can be certain it meets stringent safety standards.

Re:Charge what it costs to certify

[Rockoon]

Also to add:

The Kefauver Harris Amendment was inspired by the thalidomide tragedy that caused thousands of birth defects. However, the number of birth defects it caused in America was 0 because thalidomide was not approved yet by the FDA simply on the safety mandate. Thalidomide would have passed efficacy tests because it was, in fact, effective for more that a few purposes. So effective it was for so many purposes that Germany had lifted regulations and even started selling it over the counter.

Mandating efficacy is the backwards thinking of the Statist.

Re:Charge what it costs to certify

[sycodon]

Because INS, "Homeland" Security (What a freaking Totalitarian sounding name), and the TSA are doing such a bang up job.

Dickheads like you are the ones shutting down Lemonade stands run by six year olds because they don't "meet regulations".