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/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