FDA: We Can't Scale To Regulate Mobile Health Apps 123
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.
Re:Charge what it costs to certify (Score:5, Interesting)
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.