Loyola University Chicago School of Law, JD 2019
Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user-friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidance, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.
Mobile medical applications – healthcare in the 21st century
Mobile medical applications are described by the Food and Drug Administration (“FDA”) as “mobile apps [that] meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.” The first push towards mobile healthcare technology was the use of software applications and certain hardware, which can be plugged into smartphones for patients to use out of the clinic. Mobile medical applications allow for patient information to be routinely logged and stored and sent securely to the patient’s medical home.
Physicians favor mobile medical applications for two main reasons. The first reason is that these devices are typically easier to use and less invasive than previous equipment. Because of this, healthcare providers can focus on discussing the patient’s health instead of collecting necessary medical data. The second is that many of the applications provide auditory or visual demonstrations of the collected data, allowing the patient to better comprehend what the doctor is discussing and participate more in their health plan.
With the rapidly increasing use of mobile medical applications, the FDA has approved a number of applications. Some of the functions of these applications include blood pressure measurement systems, diagnostic spirometers, and glucose test systems.
History of FDA guidance
On September 25, 2013, the FDA released the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. It discusses the FDA’s supervision of the applications, specifically the applications that “present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.”
An updated version of the FDA’s guidance was issued on February 9, 2015. In this guidance, the FDA relaxed its regulations for certain technologies. These modifications were made in accordance with the 21st Century Cures Act, which “loosens regulations governing development of advanced and experimental medical devices, and includes language streamlining the design of clinical trials of prescription drugs.”
The latest FDA guidance, a Digital Health Innovation Action Plan, was released in July 2017. This plan expresses the actions that the FDA has committed to in order to completely implement the software provisions of the 21st Century Cures Act. With this latest guidance, the FDA plans to foster technological advances while still providing consumers and clinicians with the promise that FDA regulated mobile medical applications are safe and effective.
Throughout its guidance, the FDA has changed the parameters in which it will exercise discretion over mobile medical applications. As of October 8, 2018, the FDA website on mobile medical applications states that the agency will exercise enforcement discretion over mobile applications that “meet the regulatory definition of a ‘device’ but post minimal risk to patients and consumers.” The agency will not expect manufacturers to register and list their applications with the FDA. The applications that fall under this category include, but are not limited to, those that provide patients with simple tools to organize and track their health information, assist patients with documenting, showing, or communicating possible medical conditions to health providers, and those that easily provide information about health conditions or treatments.
How mobile medical applications should comply with the latest FDA guidance
The guidance that was issued in 2015 details in Appendix E the compliance obligations that apply to medical devices, which include mobile medical applications. Under Appendix E, there are seven categories of requirements that must be met to be in compliance: (1) establishment registration and medical device listing; (2) investigational device exemption (IDE) requirements; (3) labeling requirements; (4) premarket submission for approval or clearance; (5) quality system registration (QS regulation; (6) medical device reporting (MDR) (adverse event reporting); and (7) correcting problems.
Mobile medical applications along with other technological advances are the future of healthcare. Manufacturers that are releasing mobile medical applications must ensure that their applications are in compliance with the regulatory requirements laid out by the FDA. The FDA also has additional publications and resources that describe each requirement in detail. With the continuous issuance of FDA guidance, it is important that mobile medical application manufacturers stay up to date on the latest information to ensure that their applications are FDA-approved.