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Wearables the rage but are they medical devices?

Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions.

Wearables may be the rage but what does your company need to do for an FDA medical device submission in the US (or do you even need one from the FDA?) with these devices that can be reconfigured and change what the product is – like tell you what your pulse is, measures your blood glucose, recommend certain healthy activities to improve your chance of surviving diabetes and the list seems to be limitless.  There is such a wide variety of what these device do now or will be able to do in the near future how do you know if they really are medical devices or are they just a consumer product or something in between?  It really depends on the intended use of the device and the indications for use of the device if they fall under the definition of a medical device per Section 201 (h) of the FD&C Act and also on a whole slew of recently released FDA Guidance documents and applicable standards that support some of these Guidance documents too.

The most common submission path for FDA for some class I and many class II products is to use a 510(k) submission.  These guidances all support this submission type and would be highly recommended to submit under this pathway if your wearable falls under these guidances and falls under a classification that requires a 510(k).

So, let’s look at this closer and see what we can figure out to help you along the way to developing that perfect medical (or non medical) wearable device that fits the market’s needs, wants, and desires too so you can sell millions of the perfect wearable medical device or not. 

What are all these new FDA Guidances about & how does that help me make this decision?

Since it seems like most wearables are used in many locations such as at school, at the office, at home, during a workout, walking the dog, at the beach, in the shower, while traveling, etc. and not just in a clinical setting like a hospital or a medical clinic (or an outpatient surgical center) that these devices now are considered under the FDA Final Guidance document for the Home Use Environment. Not all home use devices are wearables but I have worked on several consulting projects in the last couple years that are definitely home use medical devices that are wearables as well. Home Use is defined by this guidance document as:

Any environment other than a professional healthcare facility or clinical lab where a device may be used. 

This is a pretty wide definition and so many wearables will fall under home use just by this definition.  So, if you fall under this guidance document then your product should meet at least these FDA Recognized Consensus Standards[1]:

  1. ANSI/AAMI HA 60601-1-11:201 – Medical electrical equipment used in the home healthcare environment (the US National Version of IEC 60601-1-11:2010[2]) in addition to,
  2. ANSI/AAMI ES60601-1:2012 (Edition 3.1), Medical electrical equipment –General requirements for basic safety and essential performance (the US national version of IEC 60601-1:2012),
  3. IEC or ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02, Medical electrical Equipment  – Collateral standard: Electromagnetic disturbances – Requirements and tests.  This is the 4th ed. of the EMC requirements even though most medical device companies are still using the 3rd ed. for US submissions the FDA is highly recommending that the 4th ed. be used when submitting for the Home Use Environment Guidance document based on the most recent update to the Home Use Guidance of Nov 24, 2014. Note that if you already designed your product based on the 3rd ed. of IEC 60601-1-2 you may need to redesign the product to meet the 4th edition of the IEC 60601-1-2 standard per what my group’s EMC experts have discussed of recent. Another thing to consider, among many other factors is Usability of the device under
  4. ANSI/AAMI/IEC 62366:2007/(R)2013, Medical devices—Application of usability engineering to medical devices And
  5. ANSI/AAMI HE75:2009, Human factors engineering–Design of medical devices
  6. The list goes on – refer to the Home Use Guidance document for more info.

Now that we touched on the Home Use Environment what other FDA Guidances should you consider in determining if your wearable will fall under FDA regulations and if the FDA will focus it’s energy on oversight of your wearable device as you define it.  That then has to be the Mobile Medical Applications (MMA) Final Guidance, Issued February 9, 2015.  The following graphic came straight from an FDA webinar on the subject and it really helps explain the striations (3 levels) of this Guidance document.

  

There is a lot of information in this 44 page Guidance with great examples of what an MMA is and not that you should really review closely.  It will help you figure out where your device falls in this pyramid of regulation and if your product is even considered a medical device or not.  The lower on this pyramid the less regulation will be enforced by the FDA, if at all (bottom level will not be under the FDA’s purview).  The middle level the FDA doesn’t plan to enforce regulatory oversight (truly this is what they said in the FDA webinar on this subject).  Realize there are other agencies & regulations outside of the FDA that likely will apply including under the FTC and HIPAA regulation.

To truly be an MMA (the top of the pyramid) the device needs to meet the definition of a medical device of Section 201(h) of the FD&C Act and either is intended to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.  Some examples of MMA’s include control inflation or deflation of a blood-pressure cuff; MMA calibrate, control, or change settings of a cochlear implant; MMA’s that connect to bedside (or cardiac) monitors & transfer data to a central viewing station for display & active patient monitoring. 

The Lower Risk mobile apps (middle part of pyramid) that meet the medical device definition under Sect. 201(h) of the FD&C Act but are not considered MMA’s the FDA has decided not to enforce regulatory oversight at this time (Currently FDA won’t enforce design & development controls, registration, etc.).  But what happens if your device causes a major health risk (say you have a recall) or the FDA changes it’s mind down the line?  They have been known to change their minds on occasion and so I recommend from a business risk perspective to follow the regulatory requirements for your medical device OR if you want to take the risk and hope nothing happens that is something you should weigh closely before going that route.

We will continue this post in another post or two and cover additional guidances such as the “General Wellness – Policy for Low Risk Devices” and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” Guidances, Cybersecuitry, EMC, and Wireless Guidances.

If you want to learn more about these Wearable Guidance documents that are related to 510k submissions to the US FDA, I am teaching a 510k workshop in San Diego on May 4, 2015 as part of the Medical Device Group 10x Conference. Two other consultants on the Eisner Safety Consultants team will teach the workshop: Allison Komiyama and Robert Packard.


[1] Voluntary standards but highly recommend using them unless you have a better way to prove compliance with the Guidance document

[2] Note that IEC has recently published the 2nd ed of ANSI/AAMI HA 60601-1-11 in Jan of 2015 but the FDA has not added that to the Recognized Consensus Standards list yet

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