Consumer Product or Medical Device? (Or Maybe Toy?)

By Paul A. Jones and Joel E. Henry, Ph.D. (Managing Partner, Michael Best’s Missoula Office)

So when is a consumer product – say a little matchbook-sized box you wear on your wrist that keeps track of your pulse over the course of the day –a medical device?

“What difference does it make?” you might ask. Well, if you are developing that little box for market, quite possibly tens of millions of dollars of added development and testing expenses, a couple of years more development and testing time, and millions of dollars of legal fees, regulatory expenses, insurance premiums, and misc. other costs both before market introduction and after. Not to mention likely a different distribution model, a higher price point, and lower volumes.

Alas, having perused FDA Guidance on distinguishing consumer products from medical devices (including some recent draft Guidance), and talking about the matter with some of my colleagues who spend substantial time practicing in the medical device regulation space, my take is that there is a lot of gray area around this question. Which is to say, there are a lot of current and soon-to-appear products out there for which good arguments could be made that they are consumer products – and good arguments could be made that they are medical devices. And that in some cases, the answer might even hinge on whether the manufacturer labels the product a toy. And that’s a problem.

While it takes pages and pages of regulation and guidance to get there, basically the distinction between a consumer product and a medical device – according to the FDA, which is to say the people that matter here – is pretty simple: the application of the distinction, less so.

First, the distinction. If the purpose of a product is to process inputs which are collected by the product from a person (a substance, for example sweat or blood, or data, for example a pulse) and use that to diagnose or suggest treatment for a medical condition, you have a medical device. Thus, for example, a personal ECG consumers can purchase without a prescription for the purpose of determining if they should see a doctor about an arrhythmia is a medical device, and is regulated as such. And that is true regardless of the intended use (well, I think so: more later).

Now, on the above logic, you would think that a product you wear on your wrist that keeps track of your pulse would be a medical device. I mean, the only real reason to have such a device – beyond a gee whiz sort of curiosity – is to monitor your physical activity for purposes of improving (or at least monitoring) your health. Clearly a medical device, right?

Well, no. The FDA has said, in its guidance on medical devices, that it will not deem a product a medical device if it’s only intended use is to encourage or maintain a general state of health or healthy activity, and the use of the product does not entail any significant risk to the user or third parties. Thus, your smartphone app for keeping track of your pulse isn’t in fact a medical device according to the FDA. This class of products would include (among many others) things that monitor calories burned or suggest healthy menus to control weight.

On the other hand, if your exercise monitor claims it can help you manage your Type II Diabetes, you’ve got something that is a medical device and that the FDA will consider to be a medical device. (You can see, I think, how this could get confusing.)

It gets more confusing. Our exercise monitor that is marketed as a tool for helping manage Type II Diabetes is in fact a medical device according to the FDA, and thus subject to regulation as such by the FDA. But the FDA, as a matter of policy, has indicated that it will not enforce those regulations with respect to such a medical device. That’s not a regulation but a policy. Which means it can be changed pretty much any time for pretty much any reason, without going through any rule making process or seeking industry or consumer input.

The thinking, here, is not to enforce the medical device regulations in the case of medical devices that present a low risk and are aimed at helping the consumer better manage a particular medical condition where the use of the device conforms to a generally accepted medical consensus. In this case, getting more exercise is a generally accepted mechanism for managing Type II diabetes. Another example of this kind of medical device would be a device that “coaches breathing techniques and relaxation skills, which, as part of a healthy lifestyle, may help living well with migraine headaches.” But, then again, FDA guidance says that it would regulate a medical device that listened to someone’s breathing to diagnose bronchitis (and yes, there is technology that does just that).

You can see, I think, how all of this can get pretty confusing. And we have not even talked about what “low risk” means (basically, if a product is invasive – that is it involves puncturing the skin or otherwise inserting something in the body as opposed to on it, or if it involves applying something (a laser, for example) to the body that could harm the user or a third party if not used correctly, you have a product that is not low risk).

If you think you can figure all this out on your own, here is a final twist; admittedly a pretty strange twist, but I think a valid one for purposes of illustrating how much uncertainty there is as the FDA struggles to adapt to a rapidly changing technological environment.

If you’ve ever had kids, you know that you can buy toy stethoscopes. These products, at least some of which are as functional as low end “real” stethoscopes, are not regulated as medical devices. They are marketed and intended to be used as toys, and include labels that they are not to be used for medical purposes.

On the other hand, traditional stethoscopes intended for medical use are medical devices (albeit regulated with a light touch). And “smart” stethoscopes – devices that enhance, manipulate, or interpret information generated by the stethoscope – are in fact regulated as medical devices (which, given the initial example of the personal ECG product, isn’t surprising).

So, what about a “toy” smart stethoscope? Before you say that labeling it a toy doesn’t work because it is clearly capable of performing a medical function, remember that so can a dumb toy stethoscope.

The answer? I am not sure. But there is, in fact, a “business card toy ECG” on the market. At least there is as this blog goes to press. You figure it out. And if you are smart, talk to your lawyer about your thinking before you run too far with it.

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There’s an App for That: FDA Issues Final Guidance on Mobile Medical Apps

By: Seth A. Mailhot

The U.S. Food and Drug Administration (FDA) issued a final guidance September 25, 2013 titled, “Mobile Medical Applications.” The guidance sets out the scope of FDA’s enforcement discretion on medical software applications designed for mobile devices. The final guidance follows up on a draft guidance issued on July 21, 2011, and is intended to provide even more predictability and clarity for manufacturers of mobile medical apps. The final guidance provides further examples of the types of mobile medical apps to be regulated (and not regulated) by FDA. FDA has planned a Twitter chat to discuss the new guidance on September 26 at 3:30 p.m.

Much of the guidance reiterates or restates the longstanding policy set out by FDA on the regulation of software as a medical device. For example, as noted in the guidance, “when stand-alone software is used to analyze medical device data, it has traditionally been regulated as an accessory to a medical device or as medical device software.” The regulatory policy set out in the guidance applies a risk based approach to mobile medical apps. As stated in the guidance, “certain mobile medical apps can pose potential risks to public health. Moreover, certain mobile medical apps may pose risks that are unique to the characteristics of the platform on which the mobile medical app is run. . . .FDA intends to take these risks into account in assessing the appropriate regulatory oversight for these products.”

One important point to note is that with the expansion in portable computing power, almost any medical software application that operates on a current off-the-shelf operating system may be viewed as a mobile medical app subject to the guidance. According to the guidance, “mobile platforms are defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. Examples of these mobile platforms include mobile computers such as smart phones, tablet computers, or other portable computers.” While the guidance refers to “desktops” as being distinct from “mobile platforms,” the guidance does not distinguish software that may operate on both a desktop and a mobile platform due to a shared operating system.

The definition of a mobile platform is actually a departure from the draft guidance, which adhered more closely to what would typically be considered a “mobile platform.” In the draft guidance, the definition included as examples, “the iPhone®, BlackBerry® phones, Android® phones, tablet computers, or other computers that are typically used as smart phones or personal digital assistants (PDAs).” While computing technology has advanced, expanding the definition to contemplate notebooks and other slim-profile computers adds a certain layer of confusion to the guidance.

The final guidance restates and expands the policy from the draft guidance on the entities that qualify, and do not qualify, as mobile medical app manufacturers. For example, developers that create a mobile medical app based on specifications from an “author” do not qualify as a manufacturer subject to FDA regulation. Content distributors, such as the owners and operators of “Google play,” “iTunes App store,” and “BlackBerry App World,” also are not held to be mobile medical app manufacturers. The final guidance, however, fails to address what responsibility such content distributors might have in terms of complaint handling and recalls, given the control such content distributors exert over the distribution system for mobile devices1.

FDA did note that entities that distribute their mobile medical app software as a service, such as through a web-based subscription, do qualify as manufacturers. Note that this does not mean that FDA is extending into the regulation of services distributed through web-based software applications, only that the software distributed under this model would be subject to FDA regulation.

The core policy articulated in the guidance is the categories of medical software that are considered mobile medical apps, and those that are subject to enforcement discretion by FDA. FDA identifies three categories that the agency considers to be mobile medical apps:

  1. Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.
  1. Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile      platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
  1. Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.

FDA also outlines six general categories of medical software that are subject to enforcement discretion:

  1. Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
  1. Mobile apps that provide patients with simple tools to organize and track their health information.
  1. Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).
  1. Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.
  1. Mobile apps that perform simple calculations routinely used in clinical practice.
  1. Mobile apps that enable individuals to interact with PHR systems or EHR systems.

In particular, FDA expanded the types of medical imaging software that would be exempt from FDA regulation. The previous draft guidance suggested that using a magnifying function for a specific medical purpose would make the software a regulated medical device. This left the impression that using any camera or light source native to a mobile platform for a specific medical purpose might be regulated by FDA. FDA clarified that “utiliz[ing] the mobile device’s built-in camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient’s skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between healthcare providers or between healthcare providers and patients/caregivers” would not be regulated by FDA as a mobile medical app.

FDA also provided specific clinical calculations that would be exempt from FDA regulation as a medical device:

  • Body Mass Index (BMI)
  • Total Body Water / Urea Volume of Distribution or Mean arterial pressure
  • Glascow Coma Scale score
  • APGAR score
  • NIH Stroke Scale
  • Delivery date estimator

Although the guidance ostensibly deals with mobile medical apps, the policy statements on what medical software qualifies for FDA regulation may also be applied to medical software designed for desktop platforms, as the underlying basis for many of the positions articulated by FDA are founded upon longstanding polices on medical software. The issuance of this guidance provides companies with an opportunity to review product offerings to confirm whether their medical software products meet the threshold for FDA regulation. Michael Best can assist medical software companies with this review, and can advise on how to meet FDA’s regulatory requirements for mobile medical apps. Michael Best has experience with medical software submissions to FDA, and the role that the software design control process plays in FDA’s regulation of medical software.

1 This was an issue carried over from the draft guidance. FDA suggests that these content distributors “do not engage in any manufacturing functions as defined in 21 CFR Parts 803, 806, 807, and 820,” but overlooks the pervasive control some content distributors have over software updates and complaint reporting.

Is Quicker Really Better? The Overhaul of the 510(k) Process

By: Melissa M. Turczyn

On January 19, 2011, the Food and Drug Administration (the “FDA”) announced 25 steps it intends to take before year end to improve the agency’s 510(k) clearance program for medical devices. The purpose of the program is to allow medical devices to be marketed if the applicant can show that the device is substantially equivalent to a device already on the market.

In recent years, the FDA has come under increasing scrutiny by both medical device companies and outspoken critics who claimed the current process was inconsistent and slow, and has resulted in unsafe devices being cleared. The newly released action items, selected from a broader group which included more controversial proposals, are intended to speed along the approval process for medical devices (with most devices being cleared in roughly five months), while maintaining a commitment to public safety.

Action Items to be Completed before December 31, 2011:

1.The FDA will create Draft Guidance for each of the following, beginning June 15, 2011:

a. 510(k) Modifications;

b. Clinical Trials;

c. Evaluation of Automatic Class III Designations (De Novo);

d. Standards;

e. Appeals;

f. 510(k) Paradigm;

g. Pre-Submission Interactions; and

h. Product Codes.

2.  Beginning March 31, 2011, the FDA will modify certain internal and administrative matters, including the establishment of a Center Science Council, the enhancement of training provided to its internal staff and the development of a network of external experts to leverage scientific expertise found in the outside marketplace.

3.  Also beginning March 31, 2011, the FDA will begin certain programmatic and regulatory initiatives to implement new programs and improve existing processes. For example, a public meeting will be held on April 7th and 8th to provide additional information about the viewing of device photos in a public database without the disclosure of any unique proprietary information of the devices.

The Institute of Medicine (the “IOM”) is also conducting an independent evaluation of the process and will provide feedback to the FDA on certain controversial issues, including the scope and grounds for rescinding a 510(k) clearance, providing greater authority for postmarket surveillance, and providing clarification on when a device should no longer be available for use as a predicate.

Although early commentators are encouraged by the proposed changes, the action items are still only proposals, meaning the final look and operation of the 510(k) clearance process remain to be seen.