Medical Software – US Regulation

Kolbrún Eydís Ottósdóttir

Regulatory Manager Nox Medical

Medical Software

Medical Device

Stand-Alone Software

Build-In Device Software

Medical Device Data System (MDDS)

Mobile Medical Applications

Clinical Decision Support System (CDSS)

Electronic Medical Record (EMR)/ Electronic Health

Record (EHR)

FDA – Medical Device

..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…affect the structure or

any function of the body of man or animals….

FDA Regulation of Medical Device

Class I (general control) - typically simple in design, manufacture and have a history of safe use, e.g hand-held surgical instruments

Most exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation.

Class II (special control) – additional methods/standards needed to provide assurances of safety and effectiveness, e.g. physiologic monitors

Typically require pre-market notification by submission and FDA review ( 510(k) clearance)

Class III (premarket application(PMA)) - sufficient information is not available to assure safety and effectiveness; e.g silicone gel-filled breast implants

Classification

assigned by the risk the medical device presents to the patient and

the level of regulatory control the FDA determines is needed to legally market the device

based upon classifications for devices currently legally marketed in the United States same intended use

same technological characteristics

Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device

When standalone software is used to analyze medical device data, it has traditionally been regulated as an accessory to a medical device or as medical device software

Prospective Changes

Draft FDA guidance (July 2011) “ 510(k) Device

Modifications: Deciding when to Submit a 510(k) for a

Change to and Existing Device”

Concrete examples of interpretation:

A device that previously only derived four parameters from an

EEG waveform is modified to derive two additional parameters

from the waveform. This change should result in a new 510(k).

If released is going to put a lot of limitation on further

development of devices after originally granted by FDA

without having to apply for a new 510(k)

Review time – New agreement between industry and

FDA, shorter review times but higher review fees

Medical Device Data System (MDDS)

Hardware/software products that transfer, store, convert

formats, and display medical device data

Does not modify the data or modify the display of the

data, and it does not by itself control the functions or

parameters of any other medical device.

Not intended to be used for active patient monitoring.

Not MDDS: General-purpose IT infrastructure used in

health care facilities that is not altered or reconfigured

outside of its manufactured specifications.

Network Router/Hub, Wireless access point

Computer monitor, pdf Software, Storage area network (SAN)

MDDS Manufacturer

Modifying a general purpose IT equipment/software or

infrastructure for purposes of interfacing with medical

devices

Labeling a general purpose IT equipment/software as a

MDDS for purposes of interfacing to medical devices

Designing and implementing custom software or

hardware for purposes of interfacing with medical devices

Only if perform functionality described in the MDDS rule

(transfer, store, display, or convert data).

Regulatory Oversight

April 2011: The MDDS final rule became effective ,

reclassifying the MDDS from Class III (premarket

application) to Class I (general control)

May 2011: Manufacturers are required to Register and List

with the FDA

April 2012: Manufacturers are required to implement a

compliant Quality System and begin reporting adverse

events

All MDDS manufacturers, including health care facilities

that manufacture MDDS, are required to follow the

requirements for Class I medical devices

FDA - Mobile Medical Applications Mobile application/apps:

„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“

Mobile platform:

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

mobile computers such as the iPhone®, BlackBerry® phones, Android® phones, tablet computers, or

other computers that are typically used as smart phones or personal digital assistants (PDAs).

“mobile medical app” is a mobile app that meets the definition of “medical device”:

MDDS

Accessory to a medical device

Transforming or making the mobile platform into a regulated medical device

Target/Intended use

to assisting individuals in their own health and wellness management.

to healthcare providers as tools to improve and facilitate the delivery of patient care.

... labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives

Mobile Medical Apps - Examples Mobile apps that are an extension of one or more medical device(s) by connecting

to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.;

e.g. remote display of data from bedside monitors, control the delivery of insulin on an insulin pump

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;

e.g. attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or

a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.

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;

e.g provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations

Mobile Apps - Not Medical Mobile apps that are electronic “copies” of medical textbooks, teaching aids or

reference materials, or are solely used to provide clinicians with training or reinforce training previously received.

Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness

Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.

E.g. dietary tracking logs, , dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions

Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions

Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.

E.g. apps that use the mobile platform as a magnifying glass

Mobile apps that perform the functionality of an electronic health record system or personal health record system.

Mobile Medical Device Manufactures Creates, designs, develops, labels, re-labels, remanufactures, modifies, or

creates a software system from multiple components. This could include a person or entity that creates a mobile medical app by using

commercial off the shelf software components and markets the product to perform as a mobile medical app;

Provides mobile medical app functionality through a “web service” or “web support” for use on a mobile platform. For example, a manufacturer of a mobile medical app that allows users to access

the application’s medical device functionality over the web is considered a mobile medical app manufacturer;

Initiates specifications or requirements for mobile medical apps or procures product development/manufacturing services from other individuals or entities (second party) for subsequent commercial distribution

Creates a mobile medical app intended to be used on a mobile platform, or that manufactures a mobile app to be supported by hardware attachments to the mobile platform with a device intended use.

Clinical Decision Support System (CDSS)

Application that analyzes data to help healthcare providers make clinical decisions. Not necessary for the intended use of a medical device/or in direct

connection to a medical device

Preventive care, diagnosis, planning/implementing treatment, follow up, etc

Purpose – improve health care

Use two or more items of patient data to generate case-specific advice

Knowledge based vs. non-knowledge based (artificial intelligence)

Currently NOT regulated FDA has set the stage for more guidance on CDS software

EHR/PHR not going to be regulated by FDA

Conflict between ONC and FDA? Is ONC (Office of the National Coordinator for Health Information

Technology )willing to let FDA lead in the CDSS area?

Resources Overview: FDA Regulation of Medical Devices:

http://www.qrasupport.com/FDA_MED_DEVICE.html

Draft Guidance for Industry and FDA Staff – Mobile Medical Applications (July 2011): http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

MDDS Rule Federal Register Notice: http://edocket.access.gpo.gov/2011/pdf/2011-3321.pdf

FDA MDDS: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/default.htm

Draft Guidance - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (July 2011): http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM265349.pdf