Background

With the spread of mobile devices such as smart phones, a variety of mobile medical applications are also being developed and innovated in a rapid pace. Proper regulation on those apps is necessary because while these apps can help to improve medical services, they may also pose a risk of providing incorrect information to doctors or patients.

In order to manage the potential risks to public health represented by mobile medical applications, on September 25, 2013, the U.S. Food and Drug Administration (“FDA”) issued the “Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff” (“FDA Guideline”). On November 4, 2013, the Ministry of Food and Drug Safety (“MFDS”) explained that the FDA Guideline corresponds to the Korean government’s regulation on mobile medical applications. Thus, a better understanding of the FDA Guideline would be helpful for companies who develop mobile medical apps for export to the United States or who intend to domestically distribute those apps.

Key Elements of the FDA Guideline

In the FDA Guideline, the FDA expresses its intention to apply its regulatory oversight to only those mobile apps that are medical devices under the definition of section 201(h) of the Federal Food, Drug, and Cosmetic Act and whose functionality could pose a risk to a patient’s safety. The FDA Guideline divides mobile apps into three subsets: (i) mobile apps that are subject to the FDA regulation because they are medical devices and their functionality could pose a risk to a patient’s safety; (ii) mobile apps that are not subject to the FDA regulation because they pose a low risk to patients although they are qualified for a medical device; and (iii) mobile apps that are not medical devices, therefore, that are not subject to the FDA regulation. Some of the examples that the FDA Guideline presents for each subset of mobile apps are as follows:

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Current Regulation on Mobile Medical Apps in Korea and Prospect

Article 2(1) of the Medical Devices Act (“MDA”) defines a “medical device” as an instrument, machine, device, material, or anything similar, which is used, alone or in combination, for humans or animals and which belongs to one of the following subsets: (i) products that are used for diagnosing, curing, alleviating, treating or preventing a disease; (ii) products that are used for diagnosing, curing, alleviating, or correcting an injury or impairment; (iii) products that are used for testing, replacing, or transforming a structure or function; and (iv) products that are used for birth control. If a mobile app meets the definition of a “medical device” under the MDA, the manufacturer of the app must obtain a manufacturing business license and a manufacturing approval for the product from the MFDS (Article 6(1) and (2) of the MDA).

Recently the MFDS made an authoritative interpretation that a mobile app that calculates the risk of prostate cancer constitutes a medical device, and the developer of the app is currently going through the process to obtain a manufacturing business license and a manufacturing approval for the product. The MFDS has made it clear that as it may be difficult for a developer to know whether an app constitutes a medical device or not, the MFDS will apply the same risk standards as specified in the FDA Guideline in determining whether a certain mobile app is a medical device, and that the regulation on medical devices only applies to those apps that pose a risk to public health, if not subject to scientific scrutiny, by providing incorrect diagnosis of a disease. The MFDS is expected to issue this month a guideline of mobile medical applications which will include the scope of regulation on medical devices, evaluation methods, GMP requirements, and post management.