US Lawmakers Plan Hearings on Medical App Regulation
The US House of Representatives ‘ Energy and Commerce committee will hold hearings over three days in mid March regarding the Food and Drug Administration’s approach to regulating mobile medical applications and telehealth products.
According to the Washington Post and a letter sent to the FDA by the committee earlier this month, the hearings will focus particularly on whether the new Medical Device Excise Tax (MDET) would apply to medical app developers or even manufacturers of smart phones and tablets if they fall under the FDA’s definition of a medical device.
The committee has also asked the FDA to specify when final or updated guidance on medical app regulations will be published, as well as whether the FDA has considered the effect of the MDET on smartphone and medical app developers. The legislators have asked the FDA to provide written replies by March 15.
Potential extension of the MDET to medical app and telehealth developers adds a significant new twist to the question of whether the FDA should take the same regulatory stance on these products as the agency does for conventional medical devices.