Templates. FDA Mobile Medical App Regulations. Your own sub headline This is an example text. Your Logo

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1 Templates FDA Mobile Medical App Regulations Your own sub headline This is an example text Your Logo

2 FDA Oversight of Medical Devices The latest Guidance from the FDA Tom Richards MD/MS Member, Board of Directors, Northwest Regional Telehealth Resource Center Emergency Department Physician, Sheridan Memorial Hospital, Sheridan Wyoming CEO, Apollo Telemedicine and MobileHealthWare Developer of the WoundMap mobile app

3 Disclaimer This webinar is intended for educational purposes only. The information in this presentation and the opinions expressed are my best attempt at explaining the recently released Mobile Medical Apps Guidance from the FDA. You should contact the FDA directly for specific questions about how the FDA Guidance may affect specific your mobile app development.

4 FDA Oversight of Medical Devices The latest Guidance from the FDA Mobile Medical Applications Guidance for Industry and FDA Staff Issued September 25, 2013 (Based on the 2011 draft) onnectedhealth/mobilemedicalapplications/default.htm NTRTC

5 Agenda 1 2 Why is the FDA choosing to regulate apps? A quick history of FDA regulation. 3 What are mobile medical apps? What apps will the FDA not regulate? What apps will the FDA regulate will the FDA not regulate? Specific Examples 7 Overview of the FDA approval process.

6 Why does the FDA want to regulate mobile medical apps? A reaction to exponential growth in the market Patel Bakul Apple App Store Opens Million Smartphone Users Worldwide will be using healthcare apps Billion smartphone and tablet users will have downloaded mobile health apps

7 FDA Oversight A very brief history FDA dates to 1906 with the passage of the Federal Food and Drugs Act and its jurisdiction encompasses - most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. NTRTC

8 FDA Oversight of Medical Devices Again - A very brief history 1989 Draft Software Policy 1996 Medical Devices; Current Good Manufacturing Practice and Quality System Regulation 2005 withdrawl of Draft Software Policy due to exponential growth in type and diversity of field 2011 Medical Device Data Systems classification system Class I (lower risk) to Class III (higher risk) NTRTC

9 FDA Oversight of Medical Devices The latest Guidance from the FDA Mobile Medical Applications Guidance for Industry and FDA Staff Issued September 25, 2013 (Based on the 2011 draft) onnectedhealth/mobilemedicalapplications/default.htm NTRTC

10 FDA Oversight of Medical Devices Guidance from the FDA not black and white rules This guidance represents the FDA s current thinking on the topic. It does not create or confer any rights for or on the any person and does not operate to bind the FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and reglations. - there s a lot of GRAY here.. And that s a good thing. Every page has the header Contains Nonbiding Recommendations Guidance documents do not establish legally enforceable responsibilities These are recommendations and suggestions not requirements - but you may still have to apply for FDA clearance. NTRTC

11 What Makes an app a mobile medical app? Design and Intended Use Software App Software program that runs on a cell phone, tablet, or other mobile device Software and accessory. Mobile Medical Application To be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device. Depending on its intended use and percieved potential risk to consumers the MMA may or may not be regulated.

12 Three types of apps regulation is determined based on risk to the public. Higher risk medical apps Most Health and Wellness Apps are not medical devices Lower risk medical apps 1. These apps are not defined as medical devices under section 201 (h) and are not regulated. 2. These apps may meet the definition of a medical app but pose a low enough risk to the public that the FDA will exercise enforcement discretion (ie not regulate them). 3. These apps are intended to be used as medical devices and, if they were to not function as intended, could pose a risk to patient safety. This is considered a mobile medical app and should be regulated.

13 FDA Oversight of Medical Devices What is the app for? Intent is key! The intended use of a mobile medical app determines whether it meets the definition of a device. If, by labeling claims, advertising materials, or oral or written statements by manufactures or their representatives the app 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 in other animals then it may be considered a mobile medical app. NTRTC

14 FDA Oversight of Medical Devices The latest Guidance from the FDA This oversight is platform neutral the FDA will not regulate mobile device manufacturers or app distrubutors. The FDA oversight then is based on functionality as it conveys risk to the public through the mobile medical devices intended use. Example: LED light NTRTC

15 FDA Oversight of Medical Devices More than just apps? Mobile Medical App Manufacturer - Creates a mobile medical app or a software system that provides users access to the medical device function through a website subscription, software as a service, or other similar means. NTRTC

16 FDA Oversight of Medical Devices The latest Guidance from the FDA Persons and entities NOT considered Mobile Medical App Manufacturers General IT - customer support services, data center or cloud hosting services, wireless carriers, and providers of software development kits Individual Providers - health care providers who develop an app solely for their own use and do not label or promote the app for use by other providers and individuals NTRTC

17 FDA Oversight of Medical Devices The latest Guidance from the FDA Persons and entities NOT considered Mobile Medical App Manufacturers customer support services, data center or cloud hosting services, wireless carriers, and providers of software development kits health care providers who develop an app solely for their own use and do not label or promote the app for use by other providers and individuals NTRTC

18 Apps the FDA has chosen to regulate. Apps that are an extension of one or more medical devices by connection to such devices. extend, control, display, store, analyze, or transmit patient-specific medical device data. EKG waveforms, PACS, actively monitor pts subject to regulations for such devices

19 Apps the FDA has chosen to regulate. Apps that Control a Medical Device control medical devices (BP cuff, Insulin pump) must comply with regulations applicable to connected medical devices Or Act as a secondary display (without altering or manupulating the image) example transmits wt or BP measurements apps that act as a secondary display but don t provide primary diagnosis and treatment decisions Class I (no premarket submission necessary general controls are adequate)

20 Apps the FDA has chosen to regulate. Apps that Perform patient-specific analysis (looks at a mole and predicts melanoma) Provide patient-specific diagnosis or treatment recommendations Examples include: apps that calculate medication dose (insulin for example) or radiation dose based on patient-specific data

21 Apps the FDA has chosen to regulate. If the FDA is already regulating it, they re going to regulate it in app form. Apps that transform a mobile platform into a regulated medical device using attachments, display screens, or other such methods. - example AliveCor heart monitor Mobile Apps that transform the mobile platform into a regulated medical device by creating a tool similar to currently regulated medical devices. Example Inulin Pump Controller

22 Apps the FDA has chosen not to regulate. Enforcement discretion based on low risk to patients. Self help, coaching, medication reminders Tools to organize and track health information Reference tools for specific conditions Tools usdd to communicate with providers Clinical Calculators for providers Apps to communicate with personal health record (PHR) or electronic health record (EHR) systems The common denominator = low risk, patient directed, self management or self directed

23 Apps the FDA has chosen not to regulate. Some psychiatric apps for instance that maintain or improve coping skills Example: moodhacker focused on self management of depression

24 Apps the FDA has chosen not to regulate. Reminder apps for pregnancy, smoking, etc Example: BabyBump tracks and shares stages of pregnancy

25 Apps the FDA has chosen not to regulate. GPS-enabled asthma management apps Example: Propeller Health or iasthma GPS Tracker HD helps users understand environmental triggers for asthma attacks

26 Apps the FDA has chosen not to regulate. Some physical therapy apps these use video or video games to motivate patients to do exercises at home Example: PT Pal a home physical therapy app

27 Apps the FDA has chosen not to regulate. Some drug interaction apps for consumers, these focus on OTC meds and herbs Example: CVS OTC drug interaction checker

28 Other apps the FDA has chosen not to regulate Asthma apps that track inhaler usage Preventative screening apps Symptom navigator apps when to seek help, provider locations, etc. Medication reminder apps

29 FDA Approval Process Initial steps. Step 1. Go to FDA.gov and look for a predicate product Step 2. Determine if you need premarket submission Step 3. Tag your app to an existing product or apply for a new FDA approval

30 THANK YOU!