Clarify Proposal on Mobile Health Care Technology Regulations

Target: Jeffrey E. Shuren, head of Food and Drug Administration’s Center for Devices and Radiological Health

Goal: Make public the final draft of what mobile health care devices will be regulated by the FDA

Software firms, particularly start-ups, are becoming increasingly concerned about the Food and Drug Administration’s growing interest in the mobile medical applications field. It has become a booming industry, with revenues multiplying by an estimated factor of seven in only the last year.

These developing applications, utilized through smart phones, are used for individual medical aid ranging from conducting simple procedures like blood pressure and body mass index calculations, to potentially performing an electrocardiogram (EKG). It could be a majorly beneficial boost in a health care system unable to provide basics to millions of citizens who do have access to the smart phone technology.

However, private firms worry, and rightfully so, that once a federal regulatory body brings its hand into the industry, potential for growth and innovation will be stunted. For various reasons, including being short-staffed, the FDA approval process can add months or years to the introduction of a device. When this delay is prolonged, companies lose vital revenue streams and are forced to close, causing not only a loss to the market, but increased unemployment.

There is a varied level of risk to consumers depending on what certain products are promising to deliver, and for that reason some devices should come under regulatory scrutiny. But companies should have access to and be aware of time sensitive risks involved with their ventures. Sign below to encourage the FDA to come forth with their plan to oversee the mobile medical device industry.


Dear Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological Health,

As you are well aware, the market for software medical aid applications is rapidly growing. Given the current climate of insufficiently delivered U.S. health care, these products have the potential to radically improve the well-being and confidence of U.S. citizens.

While we understand the necessity of regulating devices that may bring risk to consumers, it is also necessary for firms to be acutely aware of market risks and barriers to entry so that they may compete on a level commensurate with their own capabilities and resources. Please make haste in issuing a final draft of the FDA’s proposal of which devices are to be regulated in this emerging field.


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