Regulatory Considerations for Medical Device Software. Medical Device Software

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1 Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland

2 Offices: Dallas, Texas (12 employees) Tokyo, Japan (3 employees) Services: Regulatory strategy, 510(k) applications, etc. FDA inspections (prepare, manage, respond, etc.) FDA problem resolution (Warning Letter, Import Restriction, Untitled Letter, AI Requests, etc.) Quality systems (implement, improve, train, etc.) Validations (software, device, process, etc.)

3 Topics Definitions Understanding the regulations on medical device software in the EU Update on FDA regulation of medical device software Practical examples on (or coming to) the market in the EU and US

4 Definitions

5 My Definition Today: Medical Device Software Includes software, firmware, programmable logic, microprocessors, mobile apps, etc. May or may not be compiled into an executable file Includes standalone software, app hosted on a nondevice platform, cloud services executed on a remote server, software integrated into physical products, etc. Marketing and sales of the software/service/product (intended use) meets the legal definition of medical device (or IVD) in the country where distribution happens (or is planned) and/or users/patients live

6 My Definition Today: Mobile Medical App One type of standalone software Operates on some mobile platform such as phone, tablet, netbook, etc. Design and features provide ability to be used for human healthcare related purposes Marketing and sales of the product (intended use) meets the legal definition of medical device (or IVD) in the country where distribution happens or is planned May or may not be used with a wireless medical device

7 My Definition Today: Wireless Medical Device Active (powered) physical item Allows mobility due to wireless nature May or may not be wearable by the user May or may not have multiple physical components Design and features provide ability to be used for human healthcare related purposes Marketing and sales of the product (intended use) meets the legal definition of medical device (or IVD) in the country where distribution happens (or is planned)

8 Wireless Medical Device: Possible Features / Considerations Medical device as a service / apps / platforms Biomedical sensors / monitoring / compatibility Treatment / therapy / physical assistance Miniaturized hardware / firmware / power Ergonomics / wearability / usability / reliability Data communications / security / privacy / storage Technical innovation / validation / certification

9 Understanding the regulations on medical device software in the EU

10 Guidance EU: 2001 MEDDEV 2.4/1 Rev.8 (Guidelines for the Classification of Medical Devices) 3.2. Application rules Standalone software (e.g., software which is used for image enhancement) is regarded as driving or influencing the use of a device and so falls automatically into the same class Other standalone software, which is not regarded as driving or influencing the use of a device, is classified in its own right

11 Guidance Australia: 2001 Regulation of Medical Devices involving Software in Australia an Overview Software is becoming important as an information (and sometimes diagnostic) tool: assimilating large amounts of patient and device data for presentation to the patient, health professional, or device supplier Device software is reviewed for only some high risk device types. However for most medical devices involving software, software issues are currently not addressed Intention to harmonise Australian requirements with those in EU under the Medical Device Directives

12 Guidance World Health Organization: 2003 Medical Devices Regulations: Global Overview and Guiding Principles Provide guidance to Member States wishing to create or modify their own regulatory systems for medical devices Recognized that no single template will respond to the needs of every country Proposed harmonized definition: Medical device means any instrument, apparatus, implement, machine, appliance, implant software

13 Guidance: Ireland 2004

14 Guidance Sweden: 2009 Proposal for Guidelines regarding Classification of Software Based Information Systems used in Health Care Software intended for a medical purpose must be regarded as a "device" not "project", "service" and similar For patient safety, stand alone software will be regulated Boundaries between information technology (IT) and medical devices are disappearing Helpful monographs for different types of software: Electronic patient record systems Telemedicine systems Advanced decision support systems, etc.

15 Guidance EU: 2012 Qualification and Classification of stand alone software MEDDEV 2.1/6 (Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare Within the Regulatory Framework of Medical Devices) Defines criteria for qualification of stand alone software, when used in healthcare, as a medical device and the application of the classification criteria to such software Stand alone software may run on different operating systems or in virtual environments Provides some decision diagrams and illustrative examples to help in applying the classification criteria

16 Guidance GHTF: 2012 Essential Principles of Safety and Performance of Medical Devices GHTF/SG1/N68:2012 Essential principles for medical devices that incorporate software and standalone software: Designed for repeatability, reliability and performance according to the intended use Under single fault condition, appropriate means to eliminate or reduce risks Validated according to the state of the art taking into account the principles of development lifecycle, risk management, verification and validation

17 Guidance: Ireland 2014

18 Guidance: UK 2014

19 Mobile Device Software: UK Regulatory Guidance

20 Mobile Device Software: UK Regulatory Guidance

21 EU Guidance: Lifestyle and Wellbeing Apps

22 EU Regulatory Reference: Borderline Products

23 EU Regulatory Reference: Borderline Products

24 EU Regulatory Reference: Borderline Products

25 Is Your Software EU Regulated? Other Requirements Apply ISO Quality System Standard Authorized Representative, Adverse Event Reporting ISO Risk Management Standard IEC Software Lifecycle Management Labeling, Intended Use, Indications for Use MDD, Classification, Guidances Notified Body Audits, CE Marking, etc.

26 Update on FDA regulation of medical device software

27 Guidance US: 1989 General guidance on the regulatory requirements for computer products ( Draft Software Policy ) Computer products which are medical devices, and not components, parts, or accessories of other articles which are themselves medical devices [standalone software], are subject to one of four levels of regulatory control, depending on their characteristics: Automatic exemptions granted by the policy document Future exemptions granted by applying to FDA 510(k) application PMA application

28 FDA Assumption: Wireless Infers Software FDA assumes that wireless involves some automation (auto-connect, auto-send, auto-receive, etc.) Automation requires some level of software, firmware, programmed microprocessor, etc. ( software ) Software location can be imbedded into device hardware, loaded onto separate hardware (PC, tablet, phone, etc.), cloud hosting server, etc. Software unit may be standalone device, part of device or system, device accessory or portion thereof, etc.

29 Why Does Wireless Matter? FDA Regulates Software Software is a contrivance that meets the FDA definition of medical device, depending on the intended use FDA regulated software may be: Component of a more complex finished device Stand-alone finished device Component of an accessory to a device Stand-alone accessory Firmware, software, GUI, Mobile App, cloud service, etc.

30 FDA Regulatory Background: Device Classification System Class I, II, III, and unclassified devices Categorized by risk, complexity, and intended use Caution: doesn t follow rule-based system like MDD Instead, FDA uses unique Product Code structure FDA medical specialty branches oversee Product Codes Each Product Code associated with a specific regulation FDA website Classification Database contains details Application requirement NOT based on Class Instead, application type assigned by FDA Product Code Four possible types: PMA, De Novo, 510(k), exempt

31 Intended Use: FDA Definition (21 CFR 801.4) Objective intent of the persons legally responsible for the labeling of devices Includes direct expressions and circumstances surrounding the distribution Includes labeling claims, advertising matter, or oral or written statements by such persons or their representatives Includes when the device is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised One example of written labeling claim: Indications for Use

32 Indications for Use: FDA Definition (21 CFR ) A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. Included in every 510(k) application Appears in device labeling (product manual, instructions, website, marketing information, etc.) Includes either prescription or non-prescription designation Includes signature by FDA authority who clears the 510(k) type device

33 FDA Product Codes: Medical Device Software No specific software or mobile app product code! Instead, product code depends upon intended use, like any other FDA regulated medical device Existing FDA product codes apply, and different product codes have different regulatory pathways : 510(k) exempt 510(k) PMA Highly innovative software could use De Novo pathway

34 MDDS Regulation US: CFR Part 880 Medical Devices; Medical Device Data Systems (Final Rule) MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data Reclassify Medical Device Data Systems (MDDSs) from Class III (PMA) to Class I (general controls) MDDS cannot involve active patient monitoring MDDS cannot control or alter the performance of any connected medical devices MDDS devices are 510(k) exempt All other standard FDA device regulations apply

35 **Update** MDDS Guidance US: 2015 Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff New policy announced of enforcement discretion ( FDA does not intend to enforce compliance with the regulatory controls that apply ) for these devices: MDDS (prior slide) Electronic storage and retrieval of medical images Electronic transfer of medical image data between medical devices

36 Mobile Apps Guidance (Draft) US: 2011 Mobile Medical Application: Draft Guidance for Industry and Food and Drug Administration Staff Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or mobile medical apps FDA has previously clarified that 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

37 FDA Definition: Mobile Medical App Mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 The intended use of a mobile app determines whether it meets the definition of a device

38 Exclusions: Non-Device Medical Apps Electronic textbooks, references, medical teaching aids Apps used for general health and wellness like medication reminders, calorie counters, exercise suggestions intended to live a healthy lifestyle Office operations like billing, appointments, insurance Apps that assist users in some way, but not in manner intended for medical use Electronic health records, personal health records (unless data is imported into electronic record from actual medical device, then app is MDDS, monitor, etc.)

39 Mobile Apps Guidance (Final) US: 2013 Mobile Medical Application: Guidance for Industry and Food and Drug Administration Staff Included definitions, who was responsible (regulated) and who was not responsible (not regulated) regarding apps FDA provided many examples of non-device apps FDA provided many examples of mobile medical apps (device apps) as guidance to industry Final version was similar to draft version, but had some surprises Practitioners in US could now develop mobile apps in their medical practice that would not be regulated by FDA

40 **Update** Mobile Apps Guidance US: 2015 Mobile Medical Application: Guidance for Industry and Food and Drug Administration Staff FDA recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. New policy announced of enforcement discretion for many types of devices that had been fully regulated under the previous (2013) Mobile Medical Apps guidance document (next two slides) Radical change to FDA regulation of medical devices!

41 **Update** Mobile Apps Guidance: Enforcement Discretion Devices 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

42 **Update** Mobile Apps Guidance: Enforcement Discretion Devices Automate simple tasks for health care providers 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 OUG)

43 **Update** Home Use Guidance US: 2014 Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff Provides guidance in design and development of devices for home use including software products: Environmental considerations User considerations Design considerations Human factors Labeling Postmarket considerations References and other resources

44 **Update** Draft Guidance Expected US: FDA has announced that guidance documents are being developed for the following topics, related directly or indirectly to medical device software: Medical Device Decision Support Software General Wellness Product Medical Device Accessories

45 Practical examples on (or coming to) the market in the EU and US

46 Mobile Medical Software: Non-Device Use

47 Mobile Medical Software: Non-Device Examples

48 Mobile Medical Device Example: Radiological Image Viewer

49 Mobile Medical Device Example: Wearable Physiological Sensor

50 Mobile Medical Device Example: Remote Patient Monitoring

51 Mobile Medical Device Example: Patient Monitoring Software

52 Remote Patient Monitoring: FDA Database Overview

53 Remote Patient Monitoring: FDA Device Listing Details

54 Mobile Medical Device Example: Electrical Stimulation Pain Relief

55 Wearable Pain Relief: Mobile App Features

56 Mobile Medical Device Example: Glucose Monitoring Contact Lens

57 Wearable Glucose Monitoring: Data Communications & Display

58 Industry Partnership Example: Wearable Contact Lenses

59 Is Your Software FDA Regulated? Other FDA Requirements Apply Quality System Regulation Complaint Handling, Medical Device Reporting Risk Management, Software Change Control Labeling, Intended Use, Indications for Use FDA Registration & Device Listings FDA Product Codes, Classification FDA Inspections, Import/Export Requirements, etc.

60 Summary

61 Medical Device Software: Regulatory Summary Regulations and guidance exist for medical device software including standalone software and apps Such software is legally on the market in those major markets, so appropriate regulatory strategies exist Investors, partners and healthcare providers are getting more knowledgeable about the regulatory requirements Markets and regulators understand that use of wireless devices is expanding quickly in today s mobile society Device status? Plan and execute a regulatory strategy!

62 Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Q&A Kenneth L. Block, RAC FDA Regulatory Expert Dallas Tokyo

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