UNCLASSIFIED Slide 1 of 37 FDA-Regulated Mobile Medical Apps LTC David Shoemaker, PhD, RAC Deputy...

UNCLASSIFIED Slide 1 of 37

FDA-Regulated Mobile Medical Apps

LTC David Shoemaker, PhD, RAC

Deputy Director, Division of Regulated Activities and Compliance U.S. Army Medical Materiel Development Activity

[email protected]

Acquisition

FDA IPTs

Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the U.S. Army.

mailto:[email protected]


Outline• Discuss some common misconceptions regarding FDA-

regulated products.• Review key regulatory terms and definitions as they apply

to FDA-regulated medical applications (“apps”).• Understand the FDA’s current thinking regarding the

regulation of medical apps.• Determine whether a proposed clinical study is utilizing

FDA-regulated medical apps and must therefore be done in compliance with the FDA Investigational Device Exemption (IDE) regulations.


• If you intend to use the device in humans, then the answer is “yes” you are still subject to the FDA regulations.

• FDA’s viewpoint is based in part on court decisions where it has been deemed by U.S. courts to mean that a device being marketed simply by being used on patients.

I don’t intend to market my device.

Am I still subject to the FDA regulations?


Probably.FDA POLICY

(fromhttp://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073820.htm):

The Food & Drug Administration has jurisdiction over all products made from interstate components regardless of the amount present, even though the finished product has not moved in interstate commerce. Action may be taken against the product or the responsible firm when violative finished products are encountered, or when conditions of manufacture result in nonviolative interstate ingredients becoming adulterated or misbranded. The importance and the amount of the ingredient in the product, as well as the seriousness of the violation, will be considered in arriving at the decision to take action.

I don’t intend to conduct “interstate commerce”. Am I still subject to the FDA

regulations?


• FDA’s viewpoint is that ANY study collecting safety or efficacy data on an investigational device, regardless of whether it is directly supporting an FDA application, MUST abide by the FDA regulations.

I don’t intend for my study to be used to support any application to the FDA. Am I still

subject to the FDA regulations?


Definitions and TerminologyMedical Device 21 USC 321(h)

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—◦ recognized in the official National Formulary, or the United States

Pharmacopeia, or any supplement to them,◦ intended for use in the diagnosis of disease or other conditions,

or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

◦ intended to affect the structure or function of the body of man or other animals, and which does not achieve it primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.


What about Software Programs?• Any software that meets the legal definition of a device is

known as Medical Device Software.

• Software intended for analysis of patient data generated by a medical device with a view to diagnosis and monitoring.

• Software intended for use for by patients to diagnose or treat a physical or medical ailment (condition or disease).

• Software that is a component and integral part of a medical device.

• Software that is an accessory to a medical device. • Standalone software a.k.a “software-only devices”.

• Software intended to run on general purpose computers.


Guidance from FDA


• Commercial off-the-shelf computing platforms, with or without wireless connectivity, that are handheld in nature.

• Examples: iPhone®, Blackberry®, Android®, tablet computers.

Definitions and TerminologyMobile Platform


• A software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.

Definitions and TerminologyMobile Application (Mobile App)


• A mobile app that meets the definition of a “device” according to the FD&C Act, and either:

– Is used as an accessory to a regulated medical device, or– Transforms a mobile platform into a regulated medical

device.

Definitions and TerminologyMobile Medical Application

(Mobile Medical App)


Definitions and TerminologyMobile Medical App Manufacturer

• Any person or entity that manufacturers mobile medical apps in accordance with 21 CFR Parts 803, 806, and 807.

• May include anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components.

• It does NOT include entities that exclusively distribute mobile medical apps without engaging in manufacturing functions (e.g., Apple Apps store).


Mobile Platform Manufacturers

• If the mobile platform manufacturer solely distributes or markets its platform with no device intended use, they are considered a component manufacturer and are exempt from FDA quality systems requirements, registration, and listing.


Examples of mobile apps that FDA does NOT consider to be mobile

medical apps• Electronic “copies” of medical textbooks, teaching aids,

reference materials, etc.


• Apps solely used to log, record, track, evaluate, or make decisions or suggestions related to general health and wellness.


medical apps—cont’d



medical apps—cont’d• Apps that automate general office operations with

functionalities that include billing, inventory, appointments, or insurance transactions.

• Examples:– Apps that determine ICD-9 billing codes – Apps that track and trend billable hours– Apps that track medical apointments– Apps that enable insurance claims data collection



medical apps—cont’d• Apps that are generic aids and not marketed for a specific

medical indication.



medical apps—cont’d• Apps that perform the functionality of an electronic health

record system or personal health records system.


Types of Mobile Medical Apps for Which FDA Intends to Apply Regulatory

Oversight• Apps that are extensions of a medical device and control,

display, store, analyze, or transmit patient-specific medical device data.


Mobile MiM™


Types of Mobile Medical Apps for Which FDA Intends to Apply

Regulatory Oversight—cont’d• Apps that transform a mobile platform (e.g., Smartphone)

into a medical device by using attachments, display screens, or sensors.


Remotoscope


SpiroSmart

Home spirometry is gaining acceptance in the medical community because of its ability to detect pulmonary exacerbations and improve outcomes of chronic lung ailments. However, cost and usability are significant barriers to its widespread adoption. SpiroSmart is a low-cost mobile phone application that performs spirometry sensing using the built-in microphone. We evaluated SpiroSmart on 52 subjects, showing that the mean error when compared to a clinical spirometer is 5.1% for common measures of lung function. Finally, we show that pulmonologists can use SpiroSmart to diagnose varying degrees of obstructive lung ailments.


Hemoglobe

A group of biomedical engineering undergraduate students at Johns Hopkins University in Baltimore, America have possibly contrived the solution for global maternal anemia: Hemoglobe, which is a non-invasive device connected to a mobile phone to estimate the haemoglobin level of the user. With the burgeoning use of mobile phone devices amongst health care workers in remote locations around the globe, the detection of pregnant mothers with anaemia is a close reality with field testing of this new device planned for communities in Kenya early next year. Hemoglobe functions by the principle of absorption spectrophotometry: the sensor is placed over the patient’s fingertip and different wavelengths of light are emitted, which are then absorbed by the red blood cells in the capillaries. The device then measures the degree of light absorption and this transmits to a program on the mobile device to calculate the haemoglobin level.Estimated costs to produce the device are around the vicinity of US 10 to 20 dollars. The technology is not new as other medical device companies such as Masimo have developed similar devices, however the software connected to the HemoGlobe will also send an automated message to a clinical centre.


StethoCloud

A low-cost digital stethoscope that can attach to a smartphone may represent the future of saving millions of children in Third world countries. StethoCloud is is designed to listen and digitalise a patient’s breathing sounds and patterns. Those patterns are then compared against a medical database via cloud infrastructure. Then an automated report is generated though Algorithmic Artificial Intelligence Decision Support. Such software could potentially allow an earlier diagnosis of pneumonia and reduce the mortality of children in developing countries.


iBGSTAR

The innovative iBGStar® is the first blood glucose meter that can be used on its own or connected directly to an Apple iPhone® or iPod touch® to easily display, manage and communicate your diabetes information. The iBGStar meets today’s industry standards for accuracy.


MobiSante

The world’s first portable ultrasound-smartphone device was FDA approved in January 2011 and has won multiple commendations by the New England Journal of Medicine, heralding it as the next thing to dramatically change clinical medicine, decrease medical errors, improve diagnostic capability and patient care. The full package consists of a smartphone with an 8 GB Micro-SD memory card and one transducer (multiple supported transducers are available for various uses). Users are able to share images via email, USB or MMS depending on the capabilities of the smartphone and the network.


Near Eye Tool for Refractive Assessment (NETRA)

Participant look at a portable touch screen display. NETRA combines inexpensive optical elements, programmable display and interactive software components to create the equivalent of a parallax barrier display that interfaces with the human eye. Using this platform, there is a new range of interactivity for measuring several parameters of the human eye, such as refractive errors, focal range, and focusing speed.


Types of Mobile Medical Apps for Which FDA Intends to Apply

Regulatory Oversight—cont’d

• Apps that allow the user to input patient-specific information and, using formulae or a processing algorithm, output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions.


Examples

• Apps that use patient data to produce a score or index (e.g., Glasgow Coma Scale, pain index, Apgar score, NIH stroke scale, etc.).

• Apps that act as calculators to determine max dosage of local anesthesia based on patients weight.

• Apps that provide differential diagnostic tools to systematically compare and contrast clinical findings to arrive at a possible diagnosis.


Determining if a Study Must Comply with the FDA Investigational Device (IDE)

Exemption Regulations


Three critical questions to ask with respect to the Investigational Device

Exemption (IDE) regulations

• Is the study using an investigational device in a clinical investigation?

• Is the purpose of the study to determine the safety or effectiveness of the investigational device?

• Is the study exempt from the IDE requirements?


Useful Information

• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm

• http://www.imedicalapps.com/


Just think, it all started with an app!


Contact Info, LTC (ret) Shoemaker• VHF Channel 16, hail sailing vessel Nonstop• Email: [email protected]

UNCLASSIFIED Slide 1 of 37 FDA-Regulated Mobile Medical Apps LTC David Shoemaker, PhD, RAC Deputy...

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