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

Re:Charge what it costs to certify

[Rockoon]

Yes, the FDA is supposed to be enforcing efficacy. That's its entire point

"Bureau of Chemistry" was split into the "Food, Drug, and Insecticide Administration" and the "Bureau of Chemistry and Soils" in 1927, the former of which was later renamed "Food and Drug Administration"

The FDA's purpose was codified by the Pure Food and Drug Act of 1906 until the Federal Food, Drug, and Cosmetic Act of 1938 was passed.

Still at this point, the FDA's purpose was only regulating safety.

It wasnt until the Kefauver Harris Amendment of 1962 was passed that drug efficacy was considered by any federal law, Even here it wasnt until 1968 that the FDA enacted the Drug Efficacy Study Implementation that complied with the 1962 law - so the very first year that the FDA monitored efficacy was 30 years after the FFDCA, and 62 years after the PFDA.

So only 44 years of monitoring drug efficacy by the FDA, yet its original mandate has been around since 1906 and the administration has had its current name since 1927.

You've got some explaining to do: Are you being a intentionally dishonest fuck, or are you just an ignorant twat? yeah I now.. facts are hard to either know or have to defend against.