Mobile phones have become such an influential factor of our daily lives that it is almost a necessity for us. It provides efficient solutions to many tasks such as banking, shopping, and much more. With its such prevalent use, manufacturers are seeking ways to use mobile into healthcare via mobile health.
**It is important to note that this is based on the FDA’s most up-to-date guidance (published in February 9, 2015).**
FDA’s Definition of the Important Terminologies
defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. Examples of these mobile platforms include mobile computers such as smart phones, tablet computers, or other portable computers.
defined as a software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-theshelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.
Mobile Medical Application
A mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) – 7 – 4 ; and either is intended: · to be used as an accessory to a regulated medical device; or · to transform a mobile platform into a regulated medical device.
201 (h) of the FD&C Act
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory”, 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 …”
Therefore, software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud,” or on a handheld computer may be subject to device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The level of regulatory control necessary to assure safety and effectiveness varies based upon the risk the device presents to public health.
Regulated Medical Device
Defined as a product that meets the definition of device in section 201(h) of the FD&C Act and that has been cleared or approved by the FDA review of a premarket submission or otherwise classified by the FDA.
This definition can include novel devices, whether or not on a mobile platform, that the FDA will clear or approve by the review of a premarket submission or otherwise classify.
Classification of Manufacturer
Mobile Medical App Manufacturer
Any person or entity that manufactures mobile medical apps in accordance with the definitions of manufacturer in 21 CFR Parts 803, 806, 807, and 820. – 9 – 7.
A mobile medical app manufacturer may include anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include owners and operators of “Google play,” “iTunes App store,” and “BlackBerry App World.”
Persons or Entities Not Considered to be a Manufacturer
1. Manufacturers or distributors of mobile platforms who solely distribute or market their platform and do not intend the platform to be used for medical device functions.
2.Third parties who solely provide market access to mobile medical apps but do not engage in any manufacturing functions. (Defined in 21 CFR Parts 803, 806, 807, and 820)
3. Providers of tools, services or infrastructure used in the development, distribution, or use of a mobile medical app. Examples include providers of internet connectivity (i.e., internet service), providers of general purpose computer or information technology, providers that host the web service for content or software application.
4. Licensed practitioners, including physicians, dentists, and optometrists, who manufacture a mobile medical app or alter a mobile medical app solely for use in their professional practice and do not label or promote their mobile medical apps to be generally used by other licensed practitioners or other individuals.
5. Persons who manufacture mobile medical apps solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.
Brief Description of Some Regulatory Requirements:
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 Regulation (QS Regulation)
6. Medical Device Reporting (MDR) (Adverse event reporting)
7. Correcting Problems
The FDA plans on focusing on these and putting more emphasis on them:
– 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.
– 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. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
– Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.
The FDA does not plan to enforce regulation upon applications that are as follows:
-Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions.
-Provide patients with simple tools to organize and track their health information.
-Provide easy access to information related to patients’ health conditions or treatments
-Help patients document, show, or communicate potential medical conditions to health care providers; · -Automate simple tasks for health care providers; 24 21 CFR 892.2050. 25 21 CFR 892.5050
-Contains Nonbinding Recommendations
-Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems
-Intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 880.6310 OUG).
Examples of Applications the FDA intends to exercise enforcement discretion:
-Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
-Mobile apps that provide patients with simple tools to organize and track their health information
-Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference)
-Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions
-Mobile apps that perform simple calculations routinely used in clinical practice
-Mobile apps that enable individuals to interact with PHR systems or EHR systems
-Mobile apps that meet the definition of Medical Device Data Systems
The full guidance is available here
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