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The FDA Publishes a Draft Covering Policy for Low Risk Devices

In a report that we posted in September we learned that Samsung smartphone sensor technology had been dragged down by technological and legal problems. The legal issue revolved around smartphones integrating biometric sensors having to be clearly labelled as medical devices. At the time we wondered if this same problem could catch up with Apple's iDevices. Today the FDA released a draft relating to "General Wellness: Policy for Low Risk Devices." The Draft Guidance is for Industry and Food and Drug Administration Staff. On the surface it appears that simple heath sensors found in iDevices and the future Apple Watch are likely to be cleared by the FDA as not having to be labeled medical devices like is the case in Korea. Secondly, the FDA documents states that their guidance documents "do not establish legally enforceable responsibilities."


The FDA's policy draft for low risk devices states that the "Center for Devices and Radiological Health's (CDRH's) defines general wellness products as products that (1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to users' safety. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), provided these two criteria are met."


The draft further notes that "A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition)."


As long as a smart device doesn't make any outlandish health claims of being able to cure a disease or the like, there apparently won't be any need to overly regulate smart devices that provide general health information to the public.


To review the full FDA policy draft on low risk devices, click here.


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