Saturday, August 27, 2016

FDA declines to scrutinize manufacturer claims for “low risk” mhealth apps, devices. What’s the takeaway?

Here in the US of A the Food and Drug Administration holds sway over regulating medical devices and medications. They analyze claims of effectiveness and transparency from companies that produce medications and biomedical devices.  Prior to regulating such things they analyze possible risk factors of devices used on patients.

The FDA is tight lipped about approving such things, and often the US of A is the last to approve medications and devices. The U.K. and countries in the Euro-zone approve much before the FDA. Almost all device and drug manufacturers  outsource their R&D to foreign zones.

The regulatory burden is more than enormous.  It adds to the cost of development.

The scope of such regulations is enormous.

FDA said it will ease up vetting general health and wellness apps, but it will scrutinize clinical applications and devices. Does this mean the FTC will step up?

The U.S. Food and Drug Administration has issued final guidance on “low-risk” digital health apps and devices for general health management 18 months after it  came out with draft guidance.

The document offers information on the kinds of apps and devices for which it will and won’t take action. Apps promoting or maintaining a healthy weight or to assist with weight loss goals and healthy eating are OK.  The guidance says that companies can make claims that their apps and devices can help with healthy lifestyle choices to reduce the risk of chronic conditions such as Type 2 diabetes, high blood pressure and heart disease or improve their management. But those lifestyle choices have to be advocated by the likes of the American Heart Association or American Association of Clinical Endocrinologist or peer-reviewed medical journals.

So what are some examples of what’s not OK? Claims that a product will treat or diagnose obesity, an eating disorder, such as bullimia or anorexia, or an anxiety disorder. Digital health entrepreneurs are also encouraged to ask themselves the following questions:

Is the product invasive?
Is the product implanted?
Does the product involve an intervention or technology that may pose a risk to
the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
If the answer is yes to any of the above, they need to assume their products are considered clinical applications, will be scrutinized and should act accordingly.

My takeaway from the guidance is twofold. It’s a question of resources. Although there are thousands of general wellness apps, more and more medical device and pharma companies are developing digital health devices and apps of their own.  Second, the Federal Trade Commission has shown it is willing to take action against companies that it deems to be making false health claims about their apps and devices.

The distinction now is 'false claims" such as those made by Focus Education , which produces.

The Federal Trade Commission has singled out Focus Education for making what it calls unsubstantiated claims for its computer game, including that it “permanently improves” children’s focus, behavior and children with ADHD, according to a statement from the FTC.

In another consent agreement the FTC takes action against melanoma app marketing claims, and concerns over consistency. They also took action against  Moledetective  another smartphone app

FDA declines to scrutinize manufacturer claims  and shifts regulation to the Federal Trade Commission.


  1. The number of health and medical apps that are available to customers offer options to monitor a patient's health with accuracy and security. I don't see any real problem with widespread adoption of telemedicine and ehealthcare services for consumers.

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