Food and Drug Administration (“FDA”) Regulation of Mobile Health
By Catherine Barrett, Federal Working Group, Washington, DC1
The consumer electronics, IT and telecommunications industries are carefully monitoring the Food and Drug Administration’s (“FDA”) interest in creating a new body of regulations designed to govern the use and marketability of certain hardware, software applications, mobile medical apps, mobile phones and accessories. On July 21, 2011 the FDA released draft guidance entitled “Mobile Medical Applications.”2 The purpose of the draft guidance is to “inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (“mobile applications” or ‘‘mobile apps’’).”3 The FDA is responding to market demand for and supply of technologies and software applications that are intended to be used to treat patients. In early 2012, the FDA is expected to release final regulations governing software applications intended for mobile medical platforms.
According to the draft guidance, the FDA intends to regulate:
- Mobile apps used as “an extension of one or more medical device(s)” or used to display, store, analyze or transmit “patient-specific medical device data;”4
- Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices;5 and
- Mobile apps that allow the user to input patient-specific information and - using formulae or processing algorithms - output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.
The FDA defines ‘‘mobile medical apps’’ as a mobile app that meet the definition of ‘‘device’’ in section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&CAct”) (21 U.S.C. 321);6 and either (1) is used as an accessory to a regulated medical device; or (2) transforms a mobile platform into a regulated medical device.7 The focus is on “a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.”8
According to the draft guidance, the FDA does not intend to regulate:9
- General health and wellness products;
- Electronic health records (“EHR”s);
- Personal health records (“PHR”s); and
- General IT products.10
Mobile medical apps intended to provide decisional support, suggestions and/or recommendations for general health and wellness fall outside the FDA’s scope. However, if the medical app is intended to help cure, treat, and seek treatment to mitigate or diagnose “a specific disease, disorder, patient state, or any specific, identifiable health condition” it is within the FDA’s scope.11 Mobile apps that perform the functionality of an EHR system or PHR system are also out of scope.12 Finally, the draft FDA guidance notes that “By themselves, any system, or component of a system, that is solely intended for use as General IT equipment, and that is not intended for a device use under section 201(h) of the FD&C Act, would not be considered a medical device.”13
On October 19, 2011 industry representatives from “traditional medical device manufacturers, mobile app developers, online marketplaces for mobile apps, mobile platform manufacturers, telecommunications service providers, and information and communications technology companies” organized into a temporary coalition called the mHealth Regulatory Coalition14 responded to the July 2011 FDA Draft Guidelines and outlined several areas for further clarification, including:
- The approach to evaluating “intended uses” of a product articulated in the Draft Guidance is too broad and would result in unnecessary regulation of mHealth technologies;15
- The approach to regulating accessory devices in a mobile health environment;16
- The roles and responsibilities of entities involved in complex mobile systems of medical devices and non-medical products;17and
- The utility of standard software design principles to facilitate modularization of mobile medical apps.18
The FDA’s groundbreaking move into regulation of certain mobile phones, hardware, software applications and other mobile health products is an important new development for medical device manufacturers, mobile app developers, online marketplaces for mobile apps, mobile platform manufacturers, telecommunications service providers, and information and communications technology companies. The FDA is taking the lead on creating a regulatory framework that will impact a variety of industries developing, marketing and selling products that can be used in a mobile health environment. It is clear the FDA intends to use its authority to regulate mobile medical applications, but it is not clear yet how broad the FDA intends to extend its regulatory arm. The comment period for public input on the guidance closed on October 19, 2011. The FDA is expected to review the public comments and issue final regulations outlining the types of mobile medical apps the FDA intends to regulate sometime in early 2012.
Catherine Barrett is a principal consultant at the Federal Working Group in Washington, DC and is a policy fellow with the e-Health Initiative, a nonprofit representing private and public sector stakeholders committed to improving healthcare through the use of Health Information Technology (“HIT”). She received her JD and MBA from the American University Washington College of Law and Kogod School of Business, respectively. She is currently working with federal clients to help implement the Patient Protection and Affordable Care Act. She is also enrolled in the George Washington University School of Medicine, Public Health and Health Services graduate certificate program in Health Information Privacy and Security. She may be reached at email@example.com.
|2 ||Draft Guidance for Industry and Food and Drug Administration; Mobile Medical Applications; Availability, 76 Fed. Reg. 43,689 (July 21, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-07-21/pdf/2011-18537.pdf.|
Products that are built with or consist of computer and/or software components or applications are subject to regulation as devices when they meet the definition of a device in section 201(h) of the FD&C Act. That provision defines a device as ‘‘… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent …,’’ that 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 ‘‘… intended to affect the structure or any function of the body of man or other animals ….’’ Draft Guidance for Industry and Food and Drug Administration; Mobile Medical Applications; Availability, 76 Fed. Reg. 43,689 (July 21, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-07-21/pdf/2011-18537.pdf.
The FDA intends to exercise discretion to decline to pursue enforcement actions for violations of the FD&C Act and applicable regulations by a manufacturer of a mobile medical app, as specified in this guidance. This does not constitute a change in the requirements of the FD&C Act or any applicable regulations.
Thompson, Bradley M., “Comments to FDA’s Draft Guidance on Mobile Medical Applications: Docket No. FDA-2011-D-0530”, October 19, 2011, at http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf.
See DRAFT GUIDANCE, supra note 2, at 10–11 (listing electronic health records and personal health records as “mobile apps that FDA does not consider to be mobile medical apps”); Medical Devices; Medical Device Data Systems, 76 Fed. Reg. 8637, 8643 (Feb. 15, 2011) (to be codified at 21 C.F.R. § 880.6310), available at http://www.gpo.gov/fdsys/pkg/FR-2011-02-15/pdf/2011-3321.pdf.
Thompson, Bradley M., Id.
76 Fed. Reg. 8637, 8643 (Feb. 15, 2011) (to be codified at 21 C.F.R. § 880.6310), available at
The mHealth Regulatory Coalition is a temporary body of representatives from a diverse set of industries organized to provide the FDA with input to tailor and apply its existing regulatory framework to mHealth technologies.The goal of the mHealth Regulatory Coalition is to work with the FDA to write a guidance document that address what gets regulated and what does not; See http://mhealthregulatorycoalition.org.
Thompson, Bradley M., Id
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