FDA regulation

Ben Wolf, partner in Alston & Bird's Health Care Group, told MobiHealthNews how FDA staffing cuts could slow device approvals and what companies can do to stay ahead.

The judge ruled that the FDA overstepped its authority by regulating LDTs as medical devices, overturning the rule and remanding it to the HHS Secretary for review.

Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.

The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.

Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices.

By Bradley Merrill Thompson Healthcare in America needs disrupting.

By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app.

Kinsa's smartphone-connected thermometer The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process.