Please welcome Mary Weick-Brady to our growing team that can support your medical device policy, regulatory, safety certification, and quality system needs. To find out more about her background and the rest of the Eisner Safety Consultants team members please check out our Associates web page.

If you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

What’s it about: The presentation guides you through many significant issues concerning the design & development of wearable medical devices. Leo will provides an in-depth look at the FDA guidance documents that may apply to your wearables, including the Home Use Environment, Mobile Medical Applications,  Accessories, and General Wellness  guidances among additional broader based ones.

Join us for this audio conference presentation and bring your group up  to speed as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Does the FDA consider your  wearable a medical device?
• FDA’s Final Guidances on Mobile Medical Applications & Home Use Environment
• The differences between the IEC & AAMI Home Use Environment Medical Electrical Equipment and Systems Standard (60601-1-11) and it’s impact on the FDA Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Additional Regulations that may impact your Wearable device beyond the FDA

Click here for the details on the presentation & discount ($50.00 off regular price) and also some other past presentations from FX Conferences that we have presented.

Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern).  The best thing is you don’t have to travel to go to this presentation just dial in, download the material and you are set to learn from an industry expert.  As a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 (US$) discount.

Sign up now to take away some really valuable information in this fast moving industry.

What’s it about: This audio conference presentation guides attendees through many of the significant issues concerning the development of wearable medical devices. Leo provides an in-depth look at the guidance documents that may apply to your wearables, including the Mobile Medical Applications, Home Use Environment, General Wellness, and Accessories guidances among additional broader based ones.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Is your wearable a medical device per the FDA?
• FDA’s Final Mobile Medical Applications & Home Use Environment Guidances
• The differences between the IEC & AAMI versions of 60601-1-11 (Home Use Environment Medical Electrical Equipment and Systems) Standard and how it impacts your use of the Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Other Regulations that can apply to Wearables outside of FDA
• Understanding which Recognized Consensus Standards may apply to your device

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more

From the previous “Wearables the rage but are they medical devices?” blog post I indicated that to determine if Wearables are medical devices you must a) review the definition of a medical device per Section 201(h) of the FD&C Act against the intended use of the device & it’s indications for use, and b) review a slew of recently released FDA guidance documents & related standards that supports those Guidance documents.

So, let’s continue with the “General Wellness” guidance document.  The draft guidance is titled “General Wellness – Policy for Low Risk Devices”

Many wearables may fall under the category of “general wellness”. Let’s see how this guidance may apply to Wearables.

The draft guidance document was recently released on January 20, 2015.  It covers the policy for low risk products that promote a healthy lifestyle (General wellness products). This could be like a Fitbit® or similar consumer oriented type of wearable devices that are on the market (Apple Watch, Microsoft Band, etc.). The FDA from a recent webinar and in the guidance document roughly said that it does not intend to examine, regulate & enforces “general wellness” products, if they meet the low risk definition that is in the guidance document.  This doesn’t mean that other Federal Agencies or Regulations won’t regulate these devices like the FTC, FCC, HIPAA, COPA, etc.  The guidance has several lists of examples of “general wellness” devices including weight management; stress management (i.e. a mobile apps that plays music to “soothe & relax” an individual and to “manage stress”); and products that promote physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.  On the last page of the guidance there is a Decision Algorithm for General Wellness Products where the first section deals with “Does the product make only general wellness claims?” and the 2^nd part asks, “Does the product present inherent risks to a user’s safety (i.e. is the device low risk)?”  You need to make sure to clearly go through this Algorithm to decide where you product really falls.  You may want to enlist an FDA lawyer or a Regulatory Consultant if you are not familiar with the FDA regulations.

The next FDA Guidance document we will discuss is about Medical Device Accessories.  The Guidance is titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types”.  It is a draft guidance document and was issued on the same date as the “General Wellness” Guidance of 1/20/15.  The webinar that covered the “General Wellness” Draft Guidance also discussed this Guidance document and the Mobile Medical Applications Guidance as well, as they are interrelated to some extent and so it makes sense that they all have some component related to Wearables then, as well.  The Guidance deals with if the accessory needs to maintain the same classification as it’s parent device or if you can down classify the accessory and not be as restricted because of a higher classification. It depends on if the accessory has a lower risk profile than their parent device & if so may warrant being regulated in a lower class per the Guidance document.  So, less regulation on the accessory which is the theme of all the guidances in this blog post & for the Mobile Medical Applications Guidance too. The guidance advises the user of it that the FDA has jurisdiction over accessories because the definition of a medical device provided in FD&C Act Section 201(h) defines “device” to include, among other things, an “accessory”.  In the past the FDA traditionally determined classification of device accessories in 1 of 2 ways: 1) by inclusion in the same classification as the parent device thru either the 510(k) premarket notification clearance process, the PMA approval process or by inclusion in the classification regulation or order[1] for the parent device; or 2) by issuance of a unique, separate classification regulation or order for the accessory.  The scope of the guidance clarifies how FDA’s risk-based framework for classification applies to accessories to other medical devices. The guidance also describes use of the de novo classification process to classify accessories of a new type (not previously classified) under Section 513 (f)(2) of the FD&C Act.

This warps up this part of the blog post series for wearables and I will continue in a future post or two to cover additional guidances such as Cybersecuitry, EMC, and Wireless Guidances as related to Wearables.

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. To get a great last minute discount and to reserve a spot at the conference or just the workshop contact Joe Hage at jhage at MedicalDeviceEvents dot com and he will provide you a with special rate if you mention Eisner Safety Consultants referred you to him.

Two other consultants on the Eisner Safety Consultants team will teach the workshop: Allison Komiyama and Robert Packard.

It would be great to meet you at this workshop or the entire conference and learn something new at the same time.  (See end of post for discount info)

Allison Komiyama, a former FDA reviewer, will be sharing an actual 510(k) that was redacted with us. This will give us a great perspective from the reviewer viewpoint and show us what types of comments and requests for additional information are made.

Robert Packard, a regulatory and quality systems consultant, with lots of 510(k) experience, will be sharing some of his insights into putting a 510(k) together and will focus on several of the more important sections of the 510(k).  He is currently asking for feedback which areas to focus on and you can send him an rob@13485cert.com with your suggestions too.  His current plan is to discuss:

1. provide an overview of the submission requirements with some focus on 510(k) format and contents (Section 2), 
2. review of Indications for Use (Section 4), 
3. review of 510(k) Summary (Section 5), 
4. review of Device Description (Section 11), 
5. review of Substantial Equivalence (Section 12), 
6. review of Performance Testing (Sections 18-20)

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 4^th ed. of the EMC requirements even though most medical device companies are still using the 3^rd ed. for US submissions the FDA is highly recommending that the 4^th 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 3^rd ed. of IEC 60601-1-2 you may need to redesign the product to meet the 4^th 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.