The weather has cleared and SXSW is well underway! The HBInnovate team has been sharing its experiences via Twitter and blog, keeping everyone up-to-date on the innovations and creative ideas on display.

Hot at SXSW continues to be healthcare products and services that rely upon a phone or tablet. Everyone sees the tremendous potential phones and tablets have in supporting our health and wellness.  One of the most common concerns from healthcare startups has been how to do roll-out products and services compliant with The Food and Drug Administration (FDA).

Often underestimated is the role of the FDA in getting these products and services to market. We’ve met a lot of healthtech startups, some who successful obtained FDA 510k clearance while others intentionally avoid having to go through that process. Unfortunately, FDA approval is costly, time consuming, and subjects you to a number of additional regulations. The FDA has released a number of guidance documents to help tech startups through this process.

The FDA is an agency within the U.S. Department of Health and Human Services responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” The FDA classifies medical devices based on the risks associated with the device.  Devices are classified into one of three categories with escalating levels of scrutiny and regulatory control—Class I, Class II, and Class III.

The FDA has turned its focus to the world of digital health. The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. Even with FDA guidance documents, with all of this innovation, it can be difficult to determine exactly where a new product may fit on the spectrum of medical devices, if it does at all.

General Wellness. Many of us have some form of wearable fitness tracker wrapped around our wrist. Is that a medical device? The FDA released guidance for low-risk general wellness devices. This guidance clarifies when wellness devices and apps cross over into the jurisdiction of the FDA.

Generally, the FDA does not apply its oversight to devices and apps making general wellness or fitness claims, and those that do not make “any reference to diseases or conditions.” These claims include those related to weight management, fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.

However, claims that a product will treat or diagnose diseases such as obesity, an eating disorder, an anxiety disorder, autism or muscle atrophy, or a claim that a device or app will restore a structure or function impaired due to a disease or a condition, may be subject to the FDA’s oversight.

Data Management Software. What about software systems that simply transfer or display all of the data being collected? The FDA has issued guidance to inform manufacturers, distributors, and other entities making or using a Medical Device Data System (MDDS) that the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS due to the low risk they pose to patients and the importance they play in advancing digital health.

An MDDS is a hardware or software product that transfers, stores, converts formats, and displays medical device data without controlling or altering the functions or parameters of any connected medical devices. This identification does not include devices intended to be used in connection with active patient monitoring. The word “active” represents “any device that is intended to be relied upon in deciding to take immediate clinical action.” This would include devices that have the following characteristics: (i) the clinical context requires a timely response; or (ii) the clinical condition requires a timely response.

Mobile Apps. We’ve all have apps on our phones that track various data points either automatically using only the phone, through a wireless connection to a wearable device, or through information we ourselves enter. Given the rapid expansion and broad applicability of mobile apps, the FDA issued guidance to clarify the subset of mobile apps to which the FDA intends to apply its authority.

In general, if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform upon which it functions. The FDA’s oversight focuses on the functionality of the mobile app, just as with conventional devices. Mobile apps that the FDA considers to be medical devices and subject to regulatory oversight include:

  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 for use in active patient monitoring or analyzing medical device data;
  2. 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; and
  3. Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.

Although being a medical device subject to the FDA may cause some concern, once completed this may provide you with an opportunity to enter certain markets, sell to new consumers, and partner with other manufacturers that were previously unavailable.

With the new FDA Commissioner, everyone should be watching for new guidance and an easing of requirements for healthtech products and services. We’ll be monitoring the FDA activity, and keep you posted on new developments.

For more information about the FDA’s oversight of medical devices, please contact Hal Katz at (512) 703-5715 or