Product Liability Update

Overview

On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps^[1] will be regulated by the FDA and who will be required to comply with the regulations. The FDA intends to focus its oversight on mobile medical apps whose functionality poses a risk to patient safety if the mobile app malfunctions.

Which Mobile Apps are Regulated?

The FDA will regulate “mobile medical apps,” defined as mobile apps that meet the definition of device in section 201(h) of the FD&C Act and are intended:

• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device.

Whether the mobile app is a “device” under section 201(h) is determined by its intended use. If the intended use of a mobile app is for the diagnosis, cure, treatment or prevention of disease, the mobile app is a “device.” Examples of mobile medical apps include apps that:

• Display, store, analyze, convert or transmit patient-specific data. This includes: active patient supervision through remote display of data from bedside monitors, display of previously stored EEG waveforms and apps that connect to a nursing station to transmit data to a physician’s mobile device.
• Transform the mobile device into a regulated medical device. These mobile apps use mobile platforms’ built-in features, such as display screens, camera or sensors to perform medical device functions. For example: attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, attachment of electrocardiograph (“ECG”) electrodes to a mobile platform to measure and display ECG signals and use of an attached sensor or tools within the mobile platform itself to measure physiological parameters during CPR.
• Perform patient-specific analysis, diagnosis or treatment recommendations. For example, apps that use patient-specific parameters to calculate a dosage plan for radiation therapy.
• Control the operation of a medical device. For example: apps that change the settings of an implant or medical device worn on the body, alter the settings of an infusion pump or act as wireless remote controls for CT or X-Ray machines.

Certain mobile apps may meet the definition of a device under the FD&C Act, but because they pose a lower risk to the public, the FDA intends to exercise enforcement discretion. This means the FDA will not enforce requirements under the FD&C Act for this category of apps. Examples include apps that:

• Help patients self-manage their disease through coaching without providing specific treatment. For example: apps that coach patients with cardiovascular disease, hypertension, diabetes or obesity, and promote strategies for maintaining a healthy weight, getting optimal nutrition, exercising, managing salt intake or adhering to pre-determined medication schedules.
• Provide patients with tools to organize and track their health information. For example, apps that provide tools for patients with obesity, anorexia, arthritis, diabetes or heart disease to track or trend their blood pressure measurements, drug intake times, diet, daily routine or emotional state.
• Help patients document or communicate potential medical conditions to health care providers. For example, apps specifically intended for medical use that serve as videoconferencing portals for doctor and patient or utilize the mobile device’s camera to document and transmit pictures of a medical condition.
• Provide easy access to information specifically related to patients’ health conditions or treatments. These apps provide access to information, beyond an electronic copy of a medical reference, by matching patient-specific information (diagnosis, treatments, allergies or symptoms) to reference information used in clinical practice to facilitate a medical provider’s assessment of a patient. Examples include apps that are drug-to-drug interaction or drug-allergy look-up tools.
• Automate simple tasks for health care providers. For example, medical calculators for Body Mass Index (BMI) and delivery-date estimators.
• Enable patients or providers to access health record systems, such as PHR or HER.

Mobile apps that have a health or medical focus but do not meet the definition of a device under section 201(h) of the FD&C Act will not be regulated by the FDA. Examples include mobile apps that:

• Provide access to electronic copies of medical textbooks or other reference materials.
• Are intended for health care providers to use as educational tools for medical training. For example, medical flash cards and interactive anatomy diagrams or videos.
• Are intended for patient education. For example, apps to help guide patients to ask their physician appropriate questions regarding their particular disease or concern.
• Automate general office operations in a health care setting.
• Provide electronic access to medical device labeling or instructions.
• Overall, the majority of the mobile apps on the market will fit into the latter two categories and will not be the focus of the FDA’s regulation.

Who is Responsible for Complying with the Regulations?

The FDA requires compliance by manufacturers of mobile medical apps. The FDA guidance defines a “mobile medical app manufacturer” as any person or entity that initiates specifications, designs, labels or creates a software system or application for a regulated medical device.^[2] This also includes a person or entity that creates a mobile medical app by using already existing off-the-shelf software and markets the product to perform as a mobile medical app.

A mobile medical app manufacturer does not include the following entities (and therefore these entities need not register their establishments, list their products with the FDA or submit a premarket application):

• Distributors of mobile medical apps. For example, the owners and operators of “Google play,” “iTunes App store” and “BlackBerry App World.”
• Manufacturers or distributors of mobile platforms who do not intend or market their platform to be used for medical device functions.
• Licensed practitioners who manufacture mobile medical apps solely for use in their professional practice (including use by patients).
• Persons who manufacture mobile medical apps solely for use in research, teaching or analysis.

Regulations

The mobile medical apps that are the focus of the FDA’s oversight will be subject to regulations consistent with the FDA’s existing approach for medical devices. The FDA will require the mobile medical app manufacturer to satisfy the regulatory requirements applicable to the specific device classification governing the app: class I (low risk), class II or class III (high risk). The guidance provides a brief description of the regulations:

Class I: General Controls, including:

• Establishment Registration and Medical Device Listing. Manufacturers are required to register their establishments with the FDA and identify the mobile medical apps they are marketing.
• Quality System Regulation. This regulation does not prescribe in detail how a manufacturer must produce its device but does provide a framework for all manufacturers to follow to ensure that their products consistently meet requirements. Mobile medical app manufacturers are required to create procedures to design, produce and distribute their devices that result in devices that are safe and effective. Furthermore, mobile medical app manufacturers must appropriately validate their app’s interaction with the mobile platform to ensure safe and effective operation.
• Labeling requirements.
• Medical Device Reporting. Mobile medical app manufacturers must submit reports to the FDA whenever they become aware of information that reasonably suggests that a device they market may have malfunctioned or caused or contributed to a death or serious injury.
• Premarket notification. Mobile medical app manufacturers must identify the current classification covering their mobile medical app and submit the appropriate premarket materials to the FDA.
• Reporting Corrections and Removals. Mobile medical app manufacturers are required to promptly report to the FDA certain actions concerning device corrections and removals. Specifically, mobile medical app manufacturers must report any corrections made to a mobile medical app to reduce a health risk posed by the app or to remedy a violation of the FD&C Act.
• Investigational Device Exemption (IDE) for Clinical Studies of Investigational Devices. This exemption allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the FDA.

Class II: General Controls (as described for Class I), Special Controls and (for most Class II devices) Premarket Notification

Class III: General Controls (as described for Class I) and Premarket Approval

Additional Information

If a mobile app is not addressed in FDA guidance, mobile app manufacturers may contact the FDA to obtain more information on classification.^[3] The FDA will generally issue a confidential response to an inquiry by a manufacturer within 60 days of receipt of the request.

See the entire FDA Mobile Medical App Guidance at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf