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Medical software – us regulation
1. Medical Software – US Regulation
Kolbrún Eydís Ottósdóttir
Regulatory Manager Nox Medical
2. 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)
3. 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….
4. 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
5. 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
6. 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
7. 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)
8. 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).
9. 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
10. 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
11. 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
12. 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.
13. 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.
14. 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?
15. 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/DeviceRegulationand
Guidance/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/defa
ult.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/DeviceRegulationand
Guidance/GuidanceDocuments/UCM265349.pdf
